OCEAN(a)-Outcomes – Olpasiran trials of Cardiovascular Events And LipoproteiN(a) reduction – Outcomes trial

2022-501608-85-00 Protocol 20180244 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 9 May 2023 · Status Ongoing, recruitment ended · 22 EU/EEA countries · 338 sites · Protocol 20180244

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 6,338
Countries 22
Sites 338

Cardiovascular disease (atherosclerotic cardiovascular disease (ASCVD) and elevated lipoprotein (a))

To compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in subjects with atherosclerotic cardiovascular disease (ASCVD) and elevated Lp(a)

Key facts

Sponsor
Amgen Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
9 May 2023 → ongoing
Decision date (initial)
2023-05-15
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Amgen Inc.

External identifiers

EU CT number
2022-501608-85-00
WHO UTN
U1111-1285-8310
ClinicalTrials.gov
NCT05581303

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in subjects with atherosclerotic cardiovascular disease (ASCVD) and elevated Lp(a)

Secondary objectives 5

  1. "To compare the effect of treatment with olpasiran, to placebo, in subjects with ASCVD and elevated Lp(a) on the risk for: -cardiovascular death, myocardial infarction, or ischemic stroke - cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke "
  2. To compare the effect of treatment with olpasiran, to placebo, in subjects with ASCVD and elevated Lp(a) on change from baseline in Lp(a)
  3. "To compare the effect of treatment with olpasiran, to placebo, in subjects with ASCVD and elevated Lp(a) on the risk for: -myocardial infarction -CHD death or myocardial infarction -urgent coronary revascularization -coronary revascularization -CHD death -cardiovascular death -death by any cause -ischemic stroke"
  4. To evaluate the safety and tolerabilitof olpasiran administered subcutaneously compared with placebo in subjects with elevated Lp(a) and ASCVD
  5. To evaluate pharmacokinetics of olpasiran in subjects with elevated Lp(a) and ASCVD

Conditions and MedDRA coding

Cardiovascular disease (atherosclerotic cardiovascular disease (ASCVD) and elevated lipoprotein (a))

VersionLevelCodeTermSystem organ class
21.1 LLT 10051614 Arteriosclerotic cardiovascular disease 10047065

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 1 Period with 2 arms (1 arm with Olpasiran and 1 arm with Placebo).
Subjects will be randomized in a 1:1 ratio, with 1 arm being treated with Olpasiran and 1 arm with Placebo.
 Randomised Controlled Double [{"id":184894,"code":1,"name":"Subject"},{"id":184893,"code":4,"name":"Analyst"},{"id":184890,"code":2,"name":"Investigator"},{"id":184892,"code":5,"name":"Carer"},{"id":184891,"code":3,"name":"Monitor"}] AMG 890 (olpasiran) - dose 1 - Q12W: Subjects will be randomized 1:1 to receive olpasiran every 12 weeks (Q12W)
AMG 890 (olpasiran) matching placebo - Q12W: Subjects will be randomized 1:1 to receive olpasiran matching placebo every 12 weeks (Q12W)

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes
IPD plan description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available on ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05581303) and on the Amgen Clinical Trials portal (http://www.amgen.com/datasharing).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Subject has provided informed consent prior to initiation of any study specific activities/procedures
  2. Age 18 to ≤ 85 years (or ≥ legal age within the country if it is older than 18 years) at signing of informed consent
  3. Lp(a)≥ 200 nmol/L during screening by central laboratory • At least ≥ 2 weeks of stable, and optimized lipid-lowering therapy consistent with regional/local clinical practice guidelines according to investigator’s judgment prior to Screening Lp(a).
  4. History of ASCVD as evidenced by history of either: • Myocardial infarction (MI) (presumed type 1 event due to plaque rupture/erosion) and/or • Coronary revascularization by percutaneous coronary intervention (PCI)

Exclusion criteria 6

  1. Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by central laboratory during screening
  2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening
  3. History of hemorrhagic stroke
  4. History of major bleeding disorder (for example: hemophilia, von Willebrand disease, clotting factor deficiencies, etc)
  5. Major cardiovascular event (eg, myocardial infarction, unstable angina, PCI, coronary artery bypass graft, or stroke) within 4 weeks prior to Lp(a) screening or during screening
  6. Planned cardiac surgery or arterial revascularization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first

Secondary endpoints 6

  1. Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first
  2. Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
  3. Percent change from baseline to week 48 in Lp(a)
  4. • time to myocardial infarction • time to CHD death or myocardial infarction, whichever occurs first • time to urgent coronary revascularization • time to coronary revascularization • time to CHD death • time to cardiovascular death • time to death by any cause • time to ischemic stroke
  5. Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs), serious adverse events, and adverse events leading to discontinuation of investigational product
  6. serum concentration of olpasiran at selected timepoints

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Olpasiran

PRD13196083 · Product

Active substance
Olpasiran
Substance synonyms
RNA, (Cm-sp-Am-Gm-Cm-Cm-Cm-Cm-Um-(2’-deoxy-2’-fluoro)U-(2’-deoxy-2’-fluoro)A-(2’-deoxy-2’-fluoro)U-Um-Gm-Um-Um-Am-Um-Am-Cm-Gm-(3'->3')-sp-dA), 5’-[O-[(23S,28S)-37-[[(2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-23,28-bis[[[2-[2-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]ethoxy]ethyl]amino]carbonyl]-21,26,31-trioxo-3,6,9,12,15,18,35-heptaoxa-22,27,32-triazaheptacont-1-yl] hydrogen phosphorothioate], complex with RNA (Um-sp-(2’-deoxy-2’-fluoro)C-sp-Gm-(2’-deoxy-2’-fluoro)U-Am-(2’-deoxy-2’-fluoro)U-Am-Am-Cm-Am-Am-(2’-deoxy-2’-fluoro)U-Am-(2’-deoxy-2’-fluoro)A-Gm-(2’-deoxy-2’-fluoro)G-Gm-(2’-deoxy-2’-fluoro)G-Cm-sp-(2’-deoxy-2’-fluoro)U-sp-Gm), AMG 890
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
9999 Day(s)
Authorisation status
Not Authorised
MA holder
AMGEN INC
Paediatric formulation
No
Orphan designation
No

Olpasiran

PRD12878302 · Product

Active substance
Olpasiran
Substance synonyms
RNA, (Cm-sp-Am-Gm-Cm-Cm-Cm-Cm-Um-(2’-deoxy-2’-fluoro)U-(2’-deoxy-2’-fluoro)A-(2’-deoxy-2’-fluoro)U-Um-Gm-Um-Um-Am-Um-Am-Cm-Gm-(3'->3')-sp-dA), 5’-[O-[(23S,28S)-37-[[(2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-23,28-bis[[[2-[2-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]ethoxy]ethyl]amino]carbonyl]-21,26,31-trioxo-3,6,9,12,15,18,35-heptaoxa-22,27,32-triazaheptacont-1-yl] hydrogen phosphorothioate], complex with RNA (Um-sp-(2’-deoxy-2’-fluoro)C-sp-Gm-(2’-deoxy-2’-fluoro)U-Am-(2’-deoxy-2’-fluoro)U-Am-Am-Cm-Am-Am-(2’-deoxy-2’-fluoro)U-Am-(2’-deoxy-2’-fluoro)A-Gm-(2’-deoxy-2’-fluoro)G-Gm-(2’-deoxy-2’-fluoro)G-Cm-sp-(2’-deoxy-2’-fluoro)U-sp-Gm), AMG 890
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
9999 Day(s)
Authorisation status
Not Authorised
MA holder
AMGEN INC
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo for AMG 890

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

81 Total trials 22 Recruiting 51 Ended
Commercial
Sponsor organisation
Amgen Inc.
Address
1 Amgen Center Drive
City
Thousand Oaks
Postcode
91320-1799
Country
United States

Scientific contact point

Organisation
Amgen Inc.
Contact name
Medical Information

Public contact point

Organisation
Amgen Inc.
Contact name
Medical Information

Third parties 11

OrganisationCity, countryDuties
Publicis Healthcare Communications Group Limited
ORG-100044665
 London, United Kingdom Other
Syngene International Limited
ORG-100012176
 Bengaluru, India Laboratory analysis
Omnitrace Corp.
ORG-100045579
 Palm Beach Gardens, United States Other
Altasciences Compagnie Inc.
ORG-100037610
 Laval, Canada Laboratory analysis
Suvoda LLC
ORG-100043523
 Conshohocken, United States Interactive response technologies (IRT)
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Labcorp Central Laboratory Services S.a.r.l. Meyrin
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Quipment
ORG-100043496
 Nancy, France Other
Kayentis
ORG-100037894
 Meylan, France Other
OneStudyTeam
ORL-000002046
 Boston, United States Other
Excelya Greece CRO Single Member S.A.
ORG-100009224
 Nea Filadelfia, Greece On site monitoring, Code 2

Locations

22 EU/EEA countries · 338 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 170 13
Belgium Ongoing, recruitment ended 146 15
Bulgaria Ongoing, recruitment ended 112 13
Czechia Ongoing, recruitment ended 320 39
Denmark Ongoing, recruitment ended 230 16
Estonia Ongoing, recruitment ended 50 4
Finland Ongoing, recruitment ended 47 5
France Ongoing, recruitment ended 108 19
Germany Ongoing, recruitment ended 170 31
Greece Ongoing, recruitment ended 110 13
Hungary Ongoing, recruitment ended 200 17
Iceland Ongoing, recruitment ended 40 1
Italy Ongoing, recruitment ended 100 18
Lithuania Ongoing, recruitment ended 101 6
Netherlands Ongoing, recruitment ended 400 29
Norway Ongoing, recruitment ended 35 3
Poland Ongoing, recruitment ended 310 25
Portugal Ongoing, recruitment ended 70 13
Romania Ongoing, recruitment ended 88 7
Slovakia Ongoing, recruitment ended 170 21
Spain Ongoing, recruitment ended 143 22
Sweden Ongoing, recruitment ended 70 8
Rest of world
China, Canada, Korea, Republic of, Brazil, Australia, Taiwan, Hong Kong, United States, Mexico, Japan, Argentina
 — 3,148 —

Investigational sites

Austria

13 sites · Ongoing, recruitment ended
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Department of Angiology, Währinger Gürtel 18-20, Alsergrund, Vienna
University Hospital Graz
University Hospital for Internal Medicine, Clinical Department for Endocrinology and Metabolism, Auenbruggerplatz 52, 8036, Graz
Klinikum Klagenfurt Am Woerthersee
Department of Internal Medicine and Cardiology, Feschnigstrasse 11, Klagenfurt,09.Bez.:Annabichl, Klagenfurt Am Woerthersee
Konvent Der Barmherzigen Brueder
Department of Internal Medicine, Seilerstätte 2, 4020, Linz
Universitatsklinikum St. Polten
Clinical Department of Internal Medicine 3, Dunant-Platz 1, 3100, St. Poelten
Vorarlberger Krankenhausbetriebsgesellschaft MIT
VIVIT Institute, Carinagasse 47, 6800, Feldkirch
Stadt Wien - Wiener Gesundheitsverbund
3rd Med. Dept., Cardiology, Intensive Care Unit (ICU) and Chest Pain Unit (CPU), Montleartstrasse 37, Ottakring, Vienna
Klinik Hietzing
Clinical Division of Endocrinology & Metabolism, Wolkersbergenstraße 1, Hietzing, Vienna
Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department of Internal Medicine I, Müllner Hauptstraße 48, 5020, Salzburg
Krankenhaus Nord-Klinik Floridsdorf
Karl Landsteiner Institute for Cardiovascular and Critical Care Research, Bruenner Strasse 68, Floridsdorf, Vienna
Klinik Landstrabe
1st Medical Department of Diabetology, Endocrinology and Oncology, Juchgasse 25, Landstraße, Vienna
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Department of Cardiology, Währinger Gürtel 18-20, Alsergrund, Vienna
University Hospital Graz
Department of Internal Medicine / Clinical Department for Cardiology, Auenbruggerplatz 52, 8036, Graz

Belgium

15 sites · Ongoing, recruitment ended
Hopital Erasme
Cardiology, Lennikse Baan 808, 1070, Anderlecht
O.L.Vrouw van Troost
Cardiology, Kroonveldlaan 50, 9200, Dendermonde
Universitair Ziekenhuis Gent
Cardiology, Corneel Heymanslaan 10, 9000, Gent
Ziekenhuis Aan De Stroom
Cardiology, Kempenstraat 100, 2030, Antwerp
UZ Leuven
Cardiology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Cardiology, Drie Eikenstraat 655, 2650, Edegem
AZ Turnhout
Cardiology, Rubensstraat 166, 2300, Turnhout
Az Sint-Lucas & Volkskliniek
Hart- en vaatziekten, Groenebriel 1, 9000, Gent
Jessa Ziekenhuis
Cardiology, Stadsomvaart 11, 3500, Hasselt
CHU Helora
Internal Medicine, Rue Ferrer 159 Boite 1, 7100, La Louviere
Centre Hospitalier Regional De La Citadelle
Cardiology, Bld Du Douzieme-De-Ligne 1, 4000, Liege
A.Z. Sint-Maarten
Cardiology, Liersesteenweg 435, 2800, Mechelen
Ziekenhuis Oost Limburg
Cardiology, Synaps Park 1, 3600, Genk
Azorg
Cardiology, Merestraat 80, 9300, Aalst
Azorg
Cardiology, Moorselbaan 164, 9300, Aalst

Bulgaria

13 sites · Ongoing, recruitment ended
MHAT National Heart Hospital EAD
Cardiology Clinic, Department of Invasive Cardiology, Ulitsa Konyovitsa 65, 1309, Sofiya
Orpheus Medical Center OOD
N/A, Orpheus Street 4, 6000, Stara Zagora
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
First Cardiology Clinic, General Cardiology Department, Konstantin Pomyanov Str 1, 1415, Sofia
Ambulatory For Individual Practice For Specialized Medical Care Kardio EOOD
N/A, Bulevard Republika 15, 9020, Varna
MHAT National Heart Hospital EAD
Cardiology Clinic, Department of Cardiology, Ulitsa Konyovitsa 65, 1309, Sofiya
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Clinic of Cardiology, Pierre Curie Street 2, 5804, Pleven
Kalimat Medical Center Ltd.
N/A, Ricardo Vaccarini Street 10b, Apartament 21, Sofia
Diagnostic Consultative Centre Ascendent OOD
N/A, Ul.bacho Kiro 47, 1202, Sofia
Medical Center Cardiomed 2020 EOOD
N/A, Ulitsa Krivolak 9, 8801, Sliven
Medical Center Medconsult Pleven OOD
N/A, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Cardiology Clinic, Oborishte Distr., Ul.Byalo More 8, Sofia
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department of Cardiology, Ulitsa Slavyanska 62, 2700, Blagoevgrad
Medical Center Medicabilis Ltd.
N/A, Ulitsa Kliment Ohridski 3a, 1756, Sofia

Czechia

39 sites · Ongoing, recruitment ended
Endokrinologie Cerny Most s.r.o.
NA, Generala Janouska 902/17, Cerny Most, Prague 14
MUDr. Zbynek Kosek kardiologicka ambulance s.r.o.
Kardiologicka ambulance, Vondrichova 1499, 293 01, Mlada Boleslav III
Milan Kvapil s.r.o.
Diabetologicka ambulance, Lucni 1611, 263 01, Dobris
Krajska Nemocnice T Bati a.s.
Kardiologicke oddeleni, Havlickovo Nabrezi 600, 760 01, Zlin
Kardiologie a angiologie s.r.o.
Cardiology, Turkmenska 1417/8, Vrsovice, Prague
Mestska Nemocnice Ostrava Prispevkova Organizace
Kardiologie, Nemocnicni 898-20a, 702 00, Moravska Ostrava A Privoz
Vseobecna Fakultni Nemocnice V Praze
III. Interni klinika, Centrum preventivni kardiologie, U Nemocnice 504/1, 128 08, Prague 2
Kardiologicka ambulance MUDr. Ferkl s.r.o.
N/A, Palackeho 201, 541 01, Horni Predmesti
Nemocnice Ceske Budejovice a.s.
Kardiologicke oddeleni, B. Nemcove 585/54, 370 01, Ceske Budejovice 7
Nemocnice Pardubickeho kraje, a.s.
Interni klinika - Kardiologicke oddeleni, Kyjevska 44, 532 03, Pardubice
Dum zdravi Havirov s.r.o.
N/A, Karvinska 1518/5, Mesto, Havirov
Hornicka nemocnice s poliklinikou spol. s r.o.
Interni ambulance, Prazska 206/95, 418 01, Prazske Predmesti
Kardiologicka ambulance Brno s.r.o.
Kardiologicke oddeleni, Dobrovskeho 2199/23, Kralovo Pole, Brno-Kralovo Pole
Kardio Elbl s.r.o.
NA, Halasovo Namesti 597/1, Lesna, Brno-Sever
Corintez s.r.o.
N/A, Seydlerova 2451, 158 00, Prague 13
Kardio Vaclavik s.r.o.
Interni a kardiologicka ambulance, Komenskeho 724/13, 750 02, Prerov I-Mesto
Cardio Research s.r.o.
N/A, J A Bati 5645, 760 01, Zlín
Nemocnice Jihlava prispevkova organizace
Kardiologicke oddeleni, Vrchlickeho 4630/59, 586 01, Jihlava 1
Institute For Clinical And Experimental Medicine
Klinika kardiologie, Videnska 1958, 140 21, Prague 4
Kardio Holesov s.r.o.
N/A, Susilova 478/24, 769 01, Holesov
MUDr. Ladislava Harrerova
Kardiologicka ordinace, Strelecka 880, 500 02, Hradec Kralove
Preventamed s.r.o.
N/A, Domovina 774/2, 779 00, Olomouc
Fakultni Nemocnice Plzen
II interni klinika - centrum preventivni kardiologie, Edvarda Benese 1128/13, 301 00, Plzen 1
Medicus Services s.r.o.
Kardiologicka poradna, Nadrazni 1317/5, 250 01, Brandys Nad Labem
Centrum pro zdravi s.r.o.
Kardiologicka ambulance, 122, Hlinky 48, Brno-Stred
Kardio Michal Cepelak s.r.o.
NA, Krejciho Nabr. 914, 339 01, Klatovy IV
Pedicor Trial s.r.o.
N/A, Horni 266/73, Dubina, Ostrava
Jessenia a.s.
Interni oddeleni, Okruhova 1135/44, 155 00, Prague 13
Fakultni Nemocnice Hradec Kralove
I. Interni kardioangiologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
MUDr. Libor Nechvatal s.r.o.
N/A, Hybesova 289/43, Stare Brno, Brno-Stred
Edumed s.r.o.
Kardiologicka, diabetologicka a interni ambulance, Delnicke Domy 81, 550 01, Porici
MUDr. Karel Kamenik s.r.o.
N/A, Kridlovicka 55, Stare Brno, Brno-Stred
Policska nemocnice s.r.o.
Interni ambulance, Horni Predsmesti, Eimova 294, Policka
Kardiologicke centrum MUDr. Janky Skrobakove s.r.o.
NA, Korenskeho 1045/9, Smichov, Prague 5
Clinical Trials Service s.r.o.
Kardiologicke oddeleni, Masarykovo Namesti 155, 686 01, Uherske Hradiste
Kardiologicka ambulance Brno s.r.o.
NA, Dobrovskeho 2199/23, Kralovo Pole, Brno-Kralovo Pole
Centrum klinickeho vyzkumu s.r.o.
Kardiologicka ambulance, Cechovska 57, 261 01, Pribram VIII
University Hospital Ostrava
Interni a kardiologicka klinika, 17 Listopadu 1790 5, 708 00, Ostrava Poruba
Ordinace pro choroby srdce s.r.o.
N/A, Vilema Blodka 5683, 430 01, Chomutov

Denmark

16 sites · Ongoing, recruitment ended
Odense University Hospital
Department of Cardiology, Baagoees Alle 15, 5700, Svendborg
Slagelse Hospital
Kardiologisk Afdeling, Ingemannsvej 18, 4200, Slagelse
Aarhus University Hospital
Department of Cardiology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
Department of Cardiology, Blegdamsvej 9, 2100, Copenhagen Oe
Bispebjerg Hospital
Department of Cardiology, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Sanos A/S
Sanos Clinic, Borgergade 39, 9362, Gandrup
Herlev Hospital
Department of Cardiology, Borgmester Ib Juuls Vej 31, 2730, Herlev
Sanos A/S
Sanos Clinic, Boulevarden 19g, 7100, Vejle
Zealand University Hospital
Department of Cardiology, Sygehusvej 10, 4000, Roskilde
Sydvestjysk Sygehus
Department of Cardiology, Finsensgade 35, 6700, Esbjerg
Amager Hospital
Department of Cardiology, Italiensvej 1, 2300, Copenhagen S
Region Midtjylland
Department of Cardiology, Heibergs Alle 4, 8800, Viborg
Region Sjaelland
Department of Cardiology, Smedelundsgade 60, 4300, Holbæk
Regionshospitalet Godstrup
Department of Cardiology, Hospitalsparken 15, 7400, Herning
Sanos A/S
Sanos Clinic, Herlev Hovedgade 82, 2730, Herlev
Aalborg University Hospital
Department of Cardiology, Hospitalsbyen 1, 9260, Gistrup

Estonia

4 sites · Ongoing, recruitment ended
Center for Clinical and Basic Research AS
-, J. Parna Tn 4, Kesklinna Linnaosa, Tallinn
North Estonia Regional Hospital
Cardiology Centre, J. Sutiste Tee 19, 13419, Mustamae Linnaosa
Innomedica OÜ
-, Louna Tn 51a, 11617, Nomme Linnaosa
Tartu University Hospital
2nd Cardiology Department, A006, L. Puusepa Tn 8, Tartu Linn

Finland

5 sites · Ongoing, recruitment ended
Satucon Oy
Kuopion Tyoterveys Oy, Kirkkokatu 1 6th Floor, 70100, Kuopio
Suomen Terveystalo Oy
Terveystalo Turku, Humalistonkatu 9 11, 20100, Turku
Oulu University Hospital
Research Unit of Internal Medicine, Kajaanintie 50, 90220, Oulu
Helsinki University Central Hospital
Heart and Lung Center, Haartmaninkatu 4, 00290, Helsinki
Tampere University Hospital
Keskus Tutkimusvastaanotto, Elamanaukio 2, 33520, Tampere

France

19 sites · Ongoing, recruitment ended
Assistance Publique Hopitaux De Paris
Endocrinology and Metabolism, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Hospitalier Universitaire De Montpellier
Endocrinology-Diabetology-Nutrition, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Les Hopitaux Universitaires De Strasbourg
Internal Medicine, Endocrinology and Nutrition, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Assistance Publique Hopitaux De Marseille
Nutrition-Endocrinology-Metabolic diseases, 144 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Toulouse
Cardiology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Regional Universitaire De Tours
Cardiology, Avenue De La Republique, 37170, Chambray Les Tours
Centre Hospitalier Intercommunal Compiegne Noyon
Cardiology, 8 Avenue Henri Adnot, 60200, Compiegne
Hopital Saint Joseph
Cardiology, 26 Boulevard De Louvain, 13008, Marseille
Besancon University Hospital Center
Cardiology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Assistance Publique Hopitaux De Paris
Cardiology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire De Lille
Internal Medicine and Polyvalent Medicine, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Dijon
Cardiology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Rennes
Cardiology and Vascular Diseases, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Assistance Publique Hopitaux De Paris
Cardiology, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Nice
Cardiology, 30 Voie Romaine, 06000, Nice
Polyclinique Vauban
Cardiology, 10 Avenue Vauban, 59300, Valenciennes
Hospices Civils De Lyon
Endocrinology, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Nantes
Endocrinology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Reims
Cardiology, Rue Du General Koenig, 51092, Reims Cedex

Germany

31 sites · Ongoing, recruitment ended
Stiftung Bremer Herzen
Bremer Institut für Herz- und Kreislaufforschung (BIHKF), Senator Wessling Str 2, 28277, Bremen
Heidelberg University Hospital AöR
Innere Medizin III: Klinik für Kardiologie, Angiologie und Pneumologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH
Abteilung Klinische Studien, Bergmannstrasse 28, Wehlheiden, Kassel
ClinPhenomics CVC GmbH
Innere Medizin und Kardiologie, Schaumainkai 101-103, Sachsenhausen, Frankfurt Am Main
University of Leipzig
Klinik und Poliklinik für Kardiologie, Haus 4, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsklinikum Frankfurt AöR
Medizinischen Klinik lll - Kardiologie/Nephrologie/Angiologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
KliFoCenter GmbH
forschungszentrum-ruhr, Diakonissenstrasse 8, Mitte, Witten
Otto Von Guericke Universitat Magdeburg
Medizinische Fakultät - Institut für Klinische Chemie und Pathobiochemie, Leipziger Straße 44, Leipziger Str., Magdeburg
Studienzentrum Dr. Faulmann GbR
N/A, Löwenhainer Straße 36, Tolkewitz/seidnitz-Nord, Dresden
Charite Universitatsmedizin Berlin KöR
Zentrum für Herz-Kreislauf-Gefäßmedizin, Hindenburgdamm 30, Lichterfelde, Berlin
University Medical Center Hamburg-Eppendorf
Universitäres Herz- und Gefäßzentrum Hamburg, Klinik für Kardiologie, Martinistrasse 52, Eppendorf, Hamburg
Dr. med. Andreas Wilke, Dr. med. Andrej Malazhavy und Detelin Lalev Denchev, Fachaerzte Innere Medizin und Kardiologie Partnerschaft
N/A, Hauptkanal Links 100, Papenburg-Untenende, Papenburg
Universitaetsklinikum Aachen AöR
Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin (Med. Klinik I), Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Essen AöR
Westdeutsches Herz- und Gefäßzentrum - Klinik für Kardiologie und Angiologie, Hufelandstrasse 55, Holsterhausen, Essen
Private practice of Dr TAGGESELLE
N/A, Geschwister-Scholl-Str. 1/ Rathausplatz 63 A, 04416, Markkleeberg
Evangelisches Krankenhaus Goettingen-Weende gGmbH
Nephrologisches Zentrum Göttingen GbR, An der Lutter 24, 37075, Goettingen
German Heart Centre
Klinik für Herz-Kreislaufkrankheit, Lazarettstrasse 36, Neuhausen-Nymphenburg, Munich
Universitat Heidelberg
V. Medizinische Klinik, Nephrologie und Lipidemiologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Technische Universitat Dresden
Abteilung Metabolisch Vaskuläre Medizin, Studienzentrum für Stoffwechselerkrankungen, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsmedizin Goettingen
Kardiologie und Pneumologie, Robert-Koch-Strasse 40, Weende, Goettingen
Cardiologicum Hamburg GbR
Studienzentrale, Schlossgarten 7, Marienthal, Hamburg
Klinik am See
Reha-Fachklinik Innere Medizin Kardiologie, Seebad 84, 15562, Rüdersdorf
Charite Universitatsmedizin Berlin KöR
Lipidambulanz/Lipidapharese, Stoffwechselzentrum, Augustenburger Platz 1, Wedding, Berlin
Rostock University Medical Center
Zentrum für Innere Medizin, LIPIDAMBULANZ der Universität Rostock, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
University Hospital Cologne AöR
Poliklinik für Endokrinologie, Diabetologie und Präventivmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Sana-Klinikum Remscheid GmbH
Klinik I - Kardiologie, Angiologie, Pneumologie, Nephrologie und Intensivmedizin, Burger Strasse 211, Sued, Remscheid
Velocity Clinical Research GmBH
N/A, Ansbacher Strasse 17-19, Schoeneberg, Berlin
Westfaelische Wilhelms Universitaet Muenster
Klinik für Kardiologie I Koronare Kardiologie, Herzinsuffizienz, Angiologie, Gebäude A1, Albert-Schweitzer-Campus 1, Münster
Hegau-Bodensee-Klinikum Singen
Studienzentrum, Virchowstr. 10, 78224, Singen
Medical Center - University Of Freiburg
Klinik für Kardiologie und Angiologie II, Südring 15, 79189, Bad Krozingen
Herz Und Diabeteszentrum NRW Universitaetsklinik Der Ruhr Universitaet Bochum
N/A, Georgstrasse 11, Innenstadt, Bad Oeynhausen

Greece

13 sites · Ongoing, recruitment ended
Metropolitan Hospital
Preventive Cardiology, Lipid Clinic and LDL Apheresis, Ethnarchi Makariou 11, 185 47, Pireas
University General Hospital Of Heraklion
Internal Medicine, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Of Thessaloniki Ahepa
A Propedautic Pathology Clinic, 1st St Kiriakidis Str, 546 36, Thessaloniki
General Hospital Of Mytilene Vostanio
Cardiology Department, E. Vostani 48, 811 32, Mitilini
Athens Naval Hospital
Acute Cardiac Care Unit, Dinokratous 70, 115 21, Athens
University General Hospital Of Ioannina
Internal Medicine Department, Niarchou Stavrou Avenue, 455 00, Ioannina
General Hospital Of Nea Ionia Konstantopouleio Patision
Cardiology Department, Konstadopoulou Th. 3-5, 142 33, Nea Ionia
Laiko General Hospital Of Athens
A' Propedeutic Department of Medicine- Diabetes Center, Agiou Thoma (goudi) 17, 115 27, Athens
Hippokration Hospital
1st Cardiology Clinic, Vassilissas Sofias Avenue 114, 115 27, Athens
Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.
6th Cardiology Clinic, Erithrou Stavrou 4, 151 24, Maroussi
Evangelismos S.A.
D Pathology Clinic, Ipsiladou 45-47, 106 76, Athens
Alexandra Hospital
Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Department of Cardiology, Rimini 1, 124 61, Chaidari

Hungary

17 sites · Ongoing, recruitment ended
Arina Trial Research Kft.
Dr Nagy Laszlo Kardiologiai maganrendeles es SMO, Kigyo Utca 24, 5900, Oroshaza
Budapesti Szent Ferenc Korhaz
NA, Szeher Ut 73, Kerulet, Budapest
Vita Verum Medical bt.
NA, Fiskalis Ut 43, 8000, Szekesfehervar
Clinexpert Kft.
NA, Kaszasdulo Utca 5, 1033, Budapest III
BKS Research Kft.
NA, Balassi Balint Ut 16, 3000, Hatvan
Central Hospital Of Northern Pest Military Hospital
Kardiologiai Osztaly, Robert Karoly Korut 44, 1134, Budapest XIII
High Tech Medical Kft.
NA, Fazekas Utca 19-23, 1027, Budapest II
Obudai Egeszsegugyi Centrum Kft.
NA, Zarda Utca 11-13, 8900, Zalaegerszeg
Gottsegen National Cardiovascular Center
Klinikai Farmakologiai Osztaly, Kerulet, Haller Utca 29/IX., Budapest
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Kardiovaszkularis es Belgyogyaszati Centrum, Szentpeteri Kapu 72-76, 3526, Miskolc
Komaromi Selye Janos Korhaz
Kardiologiai 1 Szakrendeles, Szechenyi Utca 2, Szony, Komarom
Semmelweis University
NA, Varosmajor Utca 68, Kerulet, Budapest XII
Belvarosi Egeszseghaz Kft.
NA, Platan Sor 2-4, 8900, Zalaegerszeg
Pharma 4 Trial Kft.
NA, Torok Ignac Utca 17, 3200, Gyongyos
Lausmed Kft.
NA, Fulep Lajos Utca 15, 6500, Baja
University Of Debrecen
Kardiologiai és Szivsebeszeti Klinika, Moricz Zsigmond Korut 22, 4032, Debrecen
Pericardio Kft.
Dr Lakatos Ferenc Private Cardiology Practice, Also Koros Sor 21, 5600, Bekescsaba

Iceland

1 site · Ongoing, recruitment ended
Icelandic Heart Association
Hjartamidstodin, Holtasmari 1, 201, Kopavogur

Italy

18 sites · Ongoing, recruitment ended
ASST Grande Ospedale Metropolitano Niguarda
UO Cardiologia 4, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Centro Cardiologico Monzino S.p.A.
UO Cardiologia Interventistica 2, Via Carlo Parea 4, 20138, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UOC di Cardiologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliera Ordine Mauriziano Di Torino
UO Cardiologia, Via Ferdinando Magellano 1, 10128, Turin
Careggi University Hospital
SOD Malattie aterotrombotiche, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Policlinico Universitario Tor Vergata
UOC Cardiologia e Cardiologia Interventistica, Viale Oxford 81, 00133, Rome
Azienda Ospealiero Universitaria Policlinico Umberto I
UO Medicina interna, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta
Dipartimento Cardio-Vascolare, Via Ferdinando Palasciano Snc, 81100, Caserta
University Hospital Of Ferrara
cardiology, Cona, Via Aldo Moro 8, Ferrara
Multimedica S.p.A.
Cardiologia, Via Gaudenzio Fantoli 16/15, 20138, Milan
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
UO Emodinamica, Largo Citta' D'ippocrate 1, 84131, Salerno
Azienda Ospedaliera Universitaria Federico II Di Napoli
UOC Cardiologia, Emodinamica e UTIC, Via Sergio Pansini 5, 80131, Naples
Humanitas Research Hospital
UO Cardiologia Clinica ed Interventistica, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Unita Locale Socio Sanitaria N 8 Berica
UOC Cardiologia, Viale Ferdinando Rodolfi 37, 36100, Vicenza
Azienda Ospedaliero Universitaria Renato Dulbecco
Unità Operativa Cardiologia Emodinamica Unita Terapia Intensiva Cardiologica, Viale Europa, 88100, Catanzaro
IRCCS Azienda Ospedaliero-Universitaria Di Bologna
UO Medicina interna 1, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOC Astanteria/MCAU, Via Del Vespro 129, 90127, Palermo
Azienda Sanitaria Locale TO3
SC Cardiologia, Via Rivalta 29, 10098, Rivoli

Lithuania

6 sites · Ongoing, recruitment ended
Pirmoji Viltis UAB
Pirmoji viltis JSC, P. Luksio G. 8, Siauliu M. Sav., Siauliai
Klinikiniai Sprendimai UAB
Klinikiniai sprendimai, UAB, P. Luksio G. 3, Kauno M. Sav., Kovno
Saules seimos medicinos centras UAB
Saules Seimos Medicinos Centras, Partizanu G. 27d, Kauno M. Sav., Kaunas
Vilnius University Hospital
Department of Clinical Trials and Pharmacology, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Kardiologijos ir reabilitacijos klinika UAB
Cardiology, Rumpiskes G. 4, Klaipedos M. Sav., Klaipeda
Klinikiniai Sprendimai UAB
Clinical Research, Vilties G. 4-46, Alytaus M. Sav., Alytus

Netherlands

29 sites · Ongoing, recruitment ended
Martini Ziekenhuis / Centrum Bijzondere Tandheelkunde Martini Ziekenhuis
Research cardiology, Van Swietenplein 1, 9728 NT, Groningen
Stichting Radboud University Medical Center
Cardiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Deventer Ziekenhuis
Cardiology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Leiden University Medical Center
Cardiology, Albinusdreef 2, 2333 ZA, Leiden
University Medical Center Utrecht
Vascular medicine, Heidelberglaan 100, 3584 CX, Utrecht
Adrz
Cardiology, 's-Gravenpolderseweg 114, 4462 RA, Goes
Stichting Alrijne Zorggroep
Cardiology, Simon Smitweg 1, 2353 GA, Leiderdorp
Stichting OLVG
Cardiology, Oosterpark 9, 1091 AC, Amsterdam
Stichting Rijnstate Ziekenhuis
Vascular medicine, Wagnerlaan 55, 6815 AD, Arnhem
Stichting Zuyderland Medisch Centrum
Cardiology, Henri Dunantstraat 5, 6419 PC, Heerlen
Reinier De Graaf
Research cardiology, Reinier De Graafweg 5, 2625 AD, Delft
Amphia Hospital
Cardiology, Molengracht 21, 4818 CK, Breda
Stichting Meander Medisch Centrum
Cardiology, Maatweg 3, 3813 TZ, Amersfoort
Gelre Hospitals
Internal Medicine, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Green Heart Hospital
Cardiology, Bleulandweg 10, 2803 HH, Gouda
Dijklander Ziekenhuis
Cardiology, Maelsonstraat 3, 1624 NP, Hoorn Nh
Bravis Ziekenhuis
Internal Medicine, Boerhaavelaan 25, 4708 AE, Roosendaal
Spaarne Gasthuis
Cardiology, Boerhaavelaan 22, 2035 RC, Haarlem
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Medicine, 's-Gravendijkwal 230, 3015 CE, Rotterdam
Medisch Spectrum Twente
Thoraxcentrum Twente, Koningsplein 1, 7512 KZ, Enschede
Academisch Medisch Centrum
Vascular medicine, Meibergdreef 9, 1105 AZ, Amsterdam
Elisabeth-Tweesteden Ziekenhuis
Cardiology, Dr. Deelenlaan 5, 5042 AD, Tilburg
Ziekenhuis Rivierenland
Cardiology, President Kennedylaan 1, 4002 WP, Tiel
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Cardiology, Tegelseweg 210, 5912 BL, Venlo
Stichting Catharina Ziekenhuis
Cardiology, Michelangelolaan 2, 5623 EJ, Eindhoven
D & A Research B.V.
Cardiology, Hegedyk 9, 8601 ZR, Sneek
Maxima Medisch Centrum
Internal Medicine, De Run 4600, 5504 DB, Veldhoven
Medical Center Haaglanden
N/A, Lijnbaan 32, 2512 VA, 's-Gravenhage
Haga Hospital
Internal Medicine, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage

Norway

3 sites · Ongoing, recruitment ended
Oslo University Hospital Hf
Lipid Clinic, Trondheimsveien 235, 0586, Oslo
Oslo University Hospital Hf
Department of Endocrinology, Morbid obesity and Preventive Medicine, Trondheimsveien 235, 0586, Oslo
Skedsmo Medisinske Senter AS
Internal Medicine, Presthagaveien 20, 2020, Skedsmokorset

Poland

25 sites · Ongoing, recruitment ended
American Heart Of Poland S.A.
Cardiology, Ul. Parzeczewska 35, 95-100, Zgierz
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
Cardiology, Ul. Marcelinska 42, 60-354, Poznan
NZOZ Medica Jerzy Cygler
Cardiology, Ul. Zeglarska 6/u3, 11-500, Gizycko
American Heart Of Poland S.A.
Cardiology, Ul. Mikołaja Reja 12, 82-400, Sztum
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Internal Medicine, Ul. Gen. Karola Kniaziewicza 1/5, 91-347, Lodz
Jaroslaw Ciosek Rajtar-Medica Centrum Medyczne, Rajtar-Medica Centrum Medyczne
Cardiology, ulica Osiedle Na Lotnisku 1/U9, 31-801, Krakow
Clinical Best Solutions Sp. z o.o. S.K.
Cardiology, al. Józefa Piłsudskiego 11, 20-011, Lublin
Velocity Nova Sp. z o.o.
Cardiology, Ul. Waclawa Sieroszewskiego 34, 24-100, Pulawy
Futuremeds Sp. z o.o.
Cardiology, Ul. Legnicka 16, 53-673, Wroclaw
Slaskie Centrum Chorob Serca W Zabrzu
Cardiology, Ul. Marii Curie-Sklodowskiej 9, 41-800, Zabrze
American Heart Of Poland S.A.
Cardiology, Ul. Edukacji 102, 43-100, Tychy
American Heart Of Poland S.A.
Cardiology, Ul. Szpitalna 13, 41-300, Dabrowa Gornicza
Centermed Sp. z o.o.
Cardiology, Ul. Weteranow 46, 20-044, Lublin
Velocity Nova Sp. z o.o.
Cardiology, Ul. Peowiakow 1, 22-400, Zamosc
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
Cardiology, Ul. Grenadierow 51/59, 04-073, Warsaw
Slaskie Centrum Chorob Serca W Zabrzu
Cardiology, Ul. Marii Curie-Sklodowskiej 9, 41-800, Zabrze
National Institute Of Cardiology
Cardiology, Ul. Alpejska 42, 04-628, Warsaw
Futuremeds Sp. z o.o.
Cardiology, Ul. Sapiezynska 3, 00-215, Warsaw
Uniwersyteckie Centrum Kliniczne
Cardiology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
American Heart Of Poland S.A.
Cardiology, Ul. Wojska Polskiego 62, 97-400, Belchatow
American Heart Of Poland S.A.
Cardiology, Ul. Franklina Delano Roosevelta 2, 47-200, Kedzierzyn-Kozle
Niepubliczny Zaklad Opieki Zdrowotnej Twoja Przychodnia Sp. z o.o.
Cardiology, Ul. Krola Rogera 6, 20-857, Lublin
American Heart Of Poland S.A.
Cardiology, Ul. Topolowa 16, 32-500, Chrzanow
American Heart Of Poland S.A.
Cardiology, ul sw Andrzeja Boboli, 43-316, Bielsko-Biala
Miedziowe Centrum Zdrowia S.A.
Cardiology, Marii Sklodowskiej-Curie 54, 59-301, Lublin

Portugal

13 sites · Ongoing, recruitment ended
Lusiadas Parcerias Cascais S.A.
Internal Medicine, Rua Laura Alves Nº 12 5º, 1050-138, Lisbon
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Cardiology, Av Prof Dr Reinaldo Dos Santos, 2790-134, Carnaxide
Unidade Local De Saude Do Alto Ave E.P.E.
Cardiology, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Hospital Professor Doutor Fernando Fonseca E.P.E.
Cardiology, Itinerario Complementar 19 Acesso Ao Hospital 19, 2720-276, Amadora
Unidade Local De Saude De Matosinhos E.P.E.
Cardiology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Unidade Local De Saude De Coimbra E.P.E.
Cardiology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Centro Hospitalar Universitario Do Porto E.P.E.
Endocrinology, Largo Professor Abel Salazar, 4050-011, Porto
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)
Cardiology, Avenida De Artur Ravara, 3814-501, Aveiro
CCAB Centro Clinico Academico Braga Associacao
Cardiology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Almada-Seixal E.P.E.
Cardiology, Avenida Torrado Da Silva, 2805-267, Almada
Centro Hospitalar de Setubal E.P.E.
Cardiology, Rua Camilo Castelo Branco, 2910-446, Setubal
Centro Hospitalar De Entre O Douro E Vouga E.P.E.
Cardiology, Rua Dr Candido De Pinho, 4520-211, Santa Maria Da Feira
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Cardiology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia

Romania

7 sites · Ongoing, recruitment ended
Mat Cord Biomedica S.R.L.
Cardiology, Strada Titulescu Nicolae 11, 120133, Buzau
Spitalul Universitar De Urgenta Bucuresti
Cardiology, Splaiul Independentei 169, 050098, Bucharest
Spitalul Clinic Municipal De Urgenta Timisoara
Cardiology, Strada Dima Gheorghe Nr.5, 300079, Timisoara
Elias University Emergency Hospital
Cardiology, Bulevardul Marasti 17, 011461, Bucharest
Spitalul Clinic Judetean De Urgenta Targu Mures
Cardiology, Strada Marinescu Gheorghe 50, 540136, Targu Mures
SC. Cardio Med S.r.l.
Cardiology, Blvd 22 December 1989 No 76, 540124, Targu
Cmi Cardiologie-Dr. Mercea Corina Delia
Cardiology, str. Petre Dulfu nr 12A, Spatiu Comercial nr.1, Baia Mare

Slovakia

21 sites · Ongoing, recruitment ended
Oralek s.r.o.
Kardiologicka ambulancia, Hamuljakova 132/3, 029 01, Namestovo
Intergal s.r.o.
Ambulancia vnutorneho lekarstva, M. Culena 196/18, 038 43, Klastor Pod Znievom
Areteus s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, M. R. Stefanika 25a/3782, 075 01, Trebisov
Kardio 1 s.r.o.
Kardiologicka ambulancia, Pavla Dobsinskeho 13, 984 03, Lucenec
CardiOR s.r.o.
Kardiologicka ambulancia, Inovecka 1124/9, 911 01, Trencin
Medi M&M s.r.o.
Ambulancia vnutorneho lekarstva, Ceskoslovenskej Armady 35, 045 01, Moldava Nad Bodvou
Zarmed s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Rastislavova 45, Juh, Kosice - Juh
Národny ustav srdcovych a cievnych chorob a.s.
Ambulantne oddelenie, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
HeartCare s.r.o.
Kardiologicka ambulancia, Tacevska 3998, 085 01, Bardejov
Kardiomed Nz s.r.o.
Kardiologicka ambulancia, L. Stura 18, 940 02, Nove Zamky
Medispol s.r.o.
Kardiologicka ambulancia, Konstantinova 17, 080 01, Presov
Cardio D&R s.r.o. Kosice
Kardiologicka ambulancia, Marsala Koneva 1, Dargovskych Hrdinov, Kosice
Medical group Kosice s.r.o.
Kardiologicka ambulancia, Mudronova 29, Juh, Kosice
Kardiocentrum Nitra s.r.o.
Kardiologicka ambulancia, Spitalska 6, Stare Mesto, Nitra
Nemocnica S Poliklinikou Brezno N.O.
Kardiologicka ambulancia I., 273, Banisko 1, Brezno
Medikard s.r.o.
Ambulancia vnutorneho lekarstva, Jana Holleho 14/D, 080 01, Presov
Tatratrial s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Namestie 1. Maja 11, 048 01, Roznava
Interna SK s.r.o.
Kardiologicka ambulancia, Mudr. Pribulu 412/4, 089 01, Svidnik
Alian s.r.o.
Kardiologicka ambulancia, Sv. Jakuba 33, 085 01, Bardejov
Medilex s.r.o.
Ambulancia vnutorneho lekarstva, Zeleznicna 23, 979 01, Rimavska Sobota
Novate s.r.o.
Kardiologicka ambulancia, Liscie Udolie 57, Karlova Ves, Bratislava

Spain

22 sites · Ongoing, recruitment ended
Hospital Universitario De Cabuenes
Servicio de Cardiologia, Calle Los Prados 395, 33203, Gijón
Bellvitge University Hospital
Servicio de Medicina Interna, Carretera De La Feixa Llarga S/n, Poligono Industrial De La Zona Ranca De Barcelona, L'hospitalet De Llobregat
Hospital Clinico San Carlos
Servicio de Medicina Interna, Calle Del Profesor Martin Lagos S/n, 28040, Madrid
Hospital Universitario Virgen De La Victoria
Servicio de Cardiologia, Calle Del Arroyo Teatinos S N, 29010, Malaga
Hospital Clinic De Barcelona
Servicio de Endocrinologia y Nutricion, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Reina Sofia
Servicio de Medicina Interna, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital de Sant Joan Despi Moises Broggi
Servicio de Medicina Interna, Calle Jacint Verdaguer 90, 08970, Sant Joan Despi
Leon University Hospital
Servicio de Cardiologia, C Altos De Nava S/n, 24071, Leon
Hospital Del Mar
Servicio de Cardiologia, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Complexo Hospitalario Universitario De Vigo
Servicio de Cardiologia, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital Arnau De Vilanova De Valencia
Servicio de Cardiologia, Calle De San Clemente 12, 46015, Valencia
University Hospital Virgen Del Rocio S.L.
Servicio de Medicina Interna, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital De La Santa Creu I Sant Pau
Servicio de Cardiologia, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Germans Trias I Pujol
Unitat Polivalent d Investigacio Clinica, Ctra. Canyet S/n, Edificio General 1a Planta, Badalona
Complexo Hospitalario Universitario A Coruna
Servicio de Cardiologia, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Ramon Y Cajal
Servicio de Cardiologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Clinical Hospital Virgen De La Arrixaca
Servicio de Cardiologia, Carretera De Cartagena S/n, El Palmar, Murcia
Hospital Unviersitario Miguel Servet
Servicio de Medicina Interna, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitari Vall D Hebron
Unidad Endocrinologia/Medicina Interna, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Servicio de Endocrinologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario 12 De Octubre
Servicio de Medicina Interna, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Virgen De La Macarena
Area de Unidad Coronaria, Avenida Del Doctor Fedriani 3, 41009, Sevilla

Sweden

8 sites · Ongoing, recruitment ended
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Sahlgrenska Cardiology, Bla Straket 5, 413 46, Goteborg
Karolinska University Hospital
Medicinsk enhet kardiologi, Eugeniavagen 3, 171 64, Solna
Karolinska University Hospital
Medicinsk enhet Endokrinologi, Halsovagen, Flemingsberg, Huddinge
Kalthus Heart & Horse AB
Hjartmottagningen, S Domkyrkofors., Clemenstorget 5, Lund
PharmaSite AB
Pharmasite, Foreningsgatan 26, Malmo S:t Johannes, Malmo
Region Skane Helsingborg Hospital
Hjartmottagningen, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
Ladulaas AB
Ladulaas, Skaraborgsvagen 35e, Boras Caroli, Boras
Region Dalarna
Kardiologiska Kliniken, Vasagatan 27, Falu Kristine, Falun

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2023-07-12 2023-07-17 2023-11-10
Belgium 2023-07-13 2023-07-17 2023-11-10
Bulgaria 2023-05-31 2023-06-08 2023-11-10
Czechia 2023-08-01 2023-08-03 2023-11-10
Denmark 2023-05-09 2023-05-12 2023-11-10
Estonia 2023-06-05 2023-06-08 2023-11-10
Finland 2023-08-03 2023-08-11 2023-11-10
France 2023-05-30 2023-06-02 2023-11-10
Germany 2023-07-26 2023-07-27 2023-11-10
Greece 2023-07-05 2023-07-12 2023-11-10
Hungary 2023-07-28 2023-08-01 2023-11-10
Iceland 2023-06-30 2023-08-09 2023-11-10
Italy 2023-07-10 2023-07-11 2023-11-10
Lithuania 2023-05-31 2023-06-07 2023-11-10
Netherlands 2023-05-12 2023-05-17 2023-11-10
Norway 2023-06-29 2023-08-16 2023-11-10
Poland 2023-07-12 2023-07-13 2023-11-10
Portugal 2023-07-10 2023-07-11 2023-11-10
Romania 2023-07-07 2023-07-17 2023-11-10
Slovakia 2023-06-06 2023-06-08 2023-11-10
Spain 2023-06-16 2023-06-20 2023-11-10
Sweden 2023-08-30 2023-09-04 2023-11-10

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Serious breach SB-64220

Sponsor became aware
2024-12-13
Date of breach
2024-03-08
Submission date
2024-12-19
Member states concerned
Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Lithuania, Portugal, Romania, Spain, Sweden, Netherlands, Norway, Poland, Slovakia
Categories
Protocol, Regulation
Areas impacted
Subject safety, Subject rights, Data reliability or robustness
Benefit-risk balance changed
Yes
Description
Background
The site has 40 participants enrolled, with 408 participants in the Netherlands. Globally there are
7297 participants enrolled.
Participant Safety Management, Rights and Data Integrity Impact
There are concerns relating to Participant Safety Management and Principal Investigator (PI)
oversight.
Good Clinical Practices (GCP) and the Study Protocol were not appropriately followed, or adequately
documented, in relation to participant safety management and PI oversight of the participant care,
with significant potential risks to participant rights and data integrity.
Participants have the right to receive adequate medical care from a qualified physician for the
assessment of adverse events and to make any medical decisions necessary to ensure the
participants safety during the study.
The current issues noted, are based on full re-review of source data for two participants, triggered by
several quality signals, including the late reporting of Serious Adverse Events (SAE), due to changes
of grading of three Adverse Events (AE), in Electronic Data Capture (EDC) system.
Identification of GCP issues, together with recently identified concerns around safety management,
provides justification for the serious breach being reported. A summary is provided below:
Safety Management Issues
The information is based on re-review of two participants&#39; medical records, with seven reported AEs.
1) AE evaluation by the PI/SI in the participant&#39;s medical records are incomplete (missing
severity, seriousness, causality and action taken). The full scope of which needs to be
determined.
2) The delayed AE/SAE reporting could potentially lead to the delayed reporting of potential
endpoints.
3) The PI has verbally confirmed participant oversight, in relation to IP administration; however,
this was not documented in the two participants medical records checked.
GCP Issues and PI responsibilities (ICH GCP E6 (R3) section 2.2.2 and ICH GCP E&amp; (R3) section
2.8.2)
4) There is limited access to site, for adequate monitoring oversight, as follows:
a. Physical space constraints.
b. Inadequate number of site terminals (one) to access the participants Electronic
Medical Records (EMR).
c. Site cannot accommodate multiple day monitoring visits or space for a second CRA to
attend.
d. Site coordinators (SC) lack availability to accommodate the number of visits required
to adequately maintain site oversight.
5) Resource Concerns. The Site Coordinator (SC) confirmed the site is short staffed. Two
previous SCs left, so from Aug 2024 only two part time SCs were allocated to the study. Two
new SC were supposed to start in Oct/Nov 2024, site confirmed on 19Dec2024, that the new
SC’s will not be assigned.
6) Site coordinator (SC) Qualifications – One SC was determined not to have adequate
educational training and experience to administer Investigational Product (IP) via subcutaneous
injection. The PI verbally confirmed on-the-job training was provided, but this was
not adequately documented, until requested by Amgen.
The issue was identified as part of the first serious breach in March 2024, however, receipt of
the documentation was not received until November 2024. (CTIS reference number for prior
Serious Breach is SB-19573)
7) 17/40 late re-consents. Seventeen participants were not reconsented at the earliest
opportunity during their next study visit (visits are every 3 months). The were no safety
updates linked to the ICF amendment.
Sponsor actions
Corrective Actions:
• Immediately Dec 2024 (responsibility PI – status ongoing) - The PI has agreed to use a paper
adverse event (AE) log, signed off by the Principal or Co-Investigator for all future AEs and
SAEs. The AE log will be considered source data.
• By end Feb (responsibility Amgen – status pending) - The site has been included in Amgen
audit plan. A three-day on-site audit is scheduled for early 2025.
Corrective Actions confirmed by site on 19Dec2024:
• Dec 2024 (responsibility PI – status ongoing) – Ensure medical oversight is fully documented
in the participants Electronic Medical Records (EMR).
• Jan 2025 (responsibility PI – status ongoing) – The PI has agreed to an increase in frequency
and duration of on-site monitoring visits. Three days on-site are scheduled for Jan 2025, with
the possibility of a further two days.
A second Clinical Research Associate (CRA) electronic medical record (EMR) account is
required alongside two CRAs to be accommodated at each on-site visit.
• End Feb 2025 (responsibility PI and Amgen – status pending) - 11/40 participants have had
their source data reviewed and verified against the electronic data capture system.
A re-review of these 11/40 subjects will be undertaken, as site quality issues were not
detected through initial oversight mechanisms.
• End Apr 2025 (responsibility PI and Amgen – status pending) - For the remaining 29/40
participants, 100% of participants source documents will be reviewed, in relation to adverse
events and participant suitability to receive IP. This is to ascertain if all AEs and SAEs have
been appropriately captured, documented and reported, and to determine if medical oversight
is documented for each participant prior to IP administration.
• End Apr 2025 (responsibility PI and Amgen – status pending) - To ensure the monitoring
backlog is cleared (currently up to August 2024)
• For the duration of the study (responsibility PI – status ongoing) - The PI needs to commit to
providing sufficient time on-site for monitors, to allow timely review of all current issues and
the resolution of the backlog.
• Ongoing (responsibility PI and Amgen - Status pending) - Based on the re-review of the
eleven SDV/SDR subjects and 100% AE SDR for all subjects, further corrective actions will
be established, which may affect our timeframes for completion.
• Ongoing until the end of the study - (responsibility PI and Amgen oversight - Status pending) -
The PI confirmed that the two assigned SCs should be sufficient for the study. Amgen will
continue to monitor this closely to ensure adequate resources are assigned.
• Ongoing (responsibility Amgen – Status pending) - Review of the training provided to the
Amgen study team in relation to AE reporting and GCP requirements.
OrganisationCityCountryType
Elisabeth-Tweesteden Ziekenhuis Tilburg Netherlands Clinical investigator

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 260 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_ENG_2022-501608-85_20180244_For Publication 7
Recruitment arrangements (for publication) K1 Recruitment arrangements For Publication 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements - For Publication 2.0
Recruitment arrangements (for publication) K1_ Recruitment arrangements For Publication 2
Recruitment arrangements (for publication) K1_ Recruitment arrangements For Publication 2
Recruitment arrangements (for publication) K1_ Recruitment arrangements For Publication 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements For Publication 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements Henning Bundgaard Rigshospitalet For Publication 2
Recruitment arrangements (for publication) K1_ Recruitment arrangements site 23002_For Publication 2
Recruitment arrangements (for publication) K1_ Recruitment arrangements_For Publication 1.0
Recruitment arrangements (for publication) K1_ Recruitment arrangements_For Publication 1.0
Recruitment arrangements (for publication) K1_ Recruitment arrangements_For publication 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_For Publication 3.0
Recruitment arrangements (for publication) K1_ Recruitment arrangements_For Publication 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_procedures_FP 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements For Publication 2
Recruitment arrangements (for publication) K1_Recruitment arrangements General For Publication 2
Recruitment arrangements (for publication) K1_Recruitment arrangements NL_For Publication 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_For Publication 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_For Publication 2
Recruitment arrangements (for publication) K1_Recruitment arrangements_For Publication 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_for publication 2
Recruitment arrangements (for publication) K1_Recruitment arrangements_for publication 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Recruitment Procedure_For Publication 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_Sanos Sites_For Publication Version 1.0 - 29 Jun
Recruitment arrangements (for publication) K1_Recuitment Arrangements_20180244_FP 1
Recruitment arrangements (for publication) K2_ Recruitment material Clinic Wall Poster For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material Dr-To-Patient Letter For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material Educational Brochure 1 For Publication 1.1
Recruitment arrangements (for publication) K2_ Recruitment material Educational Brochure 1 For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material Educational Brochure 2 For Publication 1.1
Recruitment arrangements (for publication) K2_ Recruitment material Educational Brochure 2 For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material Helsinki Biobank Letter For Publication_Finnish 1
Recruitment arrangements (for publication) K2_ Recruitment material Patient Brochure For Publication 1.1
Recruitment arrangements (for publication) K2_ Recruitment material Patient Brochure For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material Physician Referral Letter_For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Clinic Poster_For publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Clinic Wall Poster_For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Clinic Wall Poster_For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Educational Brochure 1_For Publication 1.0
Recruitment arrangements (for publication) K2_ Recruitment material_Educational Brochure 1_For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Educational Brochure 1_For publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Educational Brochure 2_For Publication 1.0
Recruitment arrangements (for publication) K2_ Recruitment material_Educational Brochure 2_For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Educational Brochure 2_For publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Lp a Educational Brochure For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Lpa Educational brochure_For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Patient Brochure_For Publication 1.0
Recruitment arrangements (for publication) K2_ Recruitment material_Patient Brochure_For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Patient Brochure_For publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Patient Brochure_For Publication 1
Recruitment arrangements (for publication) K2_ Recruitment material_Physician referral letter_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment Material _Clinic Wall Poster_20180244_FP 1
Recruitment arrangements (for publication) K2_Recruitment material Clinic Wall Poster For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material Clinic Wall Poster For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material Educational Brochure 1 For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material Educational Brochure 1 For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material Educational Brochure 2 For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material Educational Brochure 2 For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material Invitation Letter Site Hjartamidstodin For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material Patient Brochure For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material Patient Brochure For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material PI to MD letter_For Publication N/A
Recruitment arrangements (for publication) K2_Recruitment material Social Media Campaign_For Publication Version 1.0 - 03 Jul
Recruitment arrangements (for publication) K2_Recruitment material_Clinic Wall Poster_Estonian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Clinic Wall Poster_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Clinic Wall Poster_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Clinic Wall Poster_Russian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Educational Brochure 1_Estonian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Educational Brochure 1_for publication 1
Recruitment arrangements (for publication) K2_Recruitment Material_Educational Brochure 1_FP 1
Recruitment arrangements (for publication) K2_Recruitment material_Educational Brochure 1_Russian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Educational Brochure 2_Estonian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Educational Brochure 2_for publication 1
Recruitment arrangements (for publication) K2_Recruitment Material_Educational Brochure 2_FP 1
Recruitment arrangements (for publication) K2_Recruitment material_Educational Brochure 2_Russian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Lp a Educational Brochure_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_Estonian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_for publication 1
Recruitment arrangements (for publication) K2_Recruitment Material_Patient Brochure_FP 1
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_Russian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Physician Referral Letter_Estonian_for publication 1
Recruitment arrangements (for publication) K2_Recruitment Material_Study Visit Guide_FP 1
Recruitment arrangements (for publication) K2_Recruitment materials_Clinic Wall Poster_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment materials_Clinic Wall Poster_Translation_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment materials_Educational Brochure 1_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment materials_Educational Brochure 1_Translation_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment materials_Educational Brochure 2_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment materials_Educational Brochure 2_Translation_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment materials_Patient Brochure_For Publication 1
Recruitment arrangements (for publication) K2_Recruitment materials_Patient Brochure_Translation_For Publication 1
Subject information and informed consent form (for publication) L1 SIS and ICF Biomarker and Future research For Publication 6.0
Subject information and informed consent form (for publication) L1 SIS and ICF Biomarker and Future research For Publication 5.0
Subject information and informed consent form (for publication) L1 SIS and ICF Main For Publication 6.0
Subject information and informed consent form (for publication) L1 SIS and ICF Main For Publication 5.0
Subject information and informed consent form (for publication) L1 SIS and ICF Pharmacogenetic For Publication 6.0
Subject information and informed consent form (for publication) L1 SIS and ICF Pharmacogenetic For Publication 5.0
Subject information and informed consent form (for publication) L1_ SIS and ICF adults main_For Publication 7.0
Subject information and informed consent form (for publication) L1_ SIS and ICF adults main_For Publication 6.0
Subject information and informed consent form (for publication) L1_ SIS and ICF adults_English_For Publication 8.00
Subject information and informed consent form (for publication) L1_ SIS and ICF adults_Translation Bulgarian_For Publication 8.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Alternate Visits Lithuanian - For Publication 4
Subject information and informed consent form (for publication) L1_ SIS and ICF Alternate Visits Russian - For Publication 4
Subject information and informed consent form (for publication) L1_ SIS and ICF Alternative visits FP 6.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Alternative visits FP 3.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Biomarker Future Research Lithuanian - For Publication 11MAY2023
Subject information and informed consent form (for publication) L1_ SIS and ICF Biomarker Future Research Russian - For Publication 11MAY2023
Subject information and informed consent form (for publication) L1_ SIS and ICF Future Research Biolomarkers FP 3.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Future Research Biomarkers FP 6.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Informed Consent Procedure For Publication 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Informed Consent Procedure For Publication 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Informed Consent Procedure FP 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Main For Publication 26JAN2026
Subject information and informed consent form (for publication) L1_ SIS and ICF Main FP 6.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Main FP 5.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Main Lithuanian_FP 27MAR2026
Subject information and informed consent form (for publication) L1_ SIS and ICF Main Russian_FP 27MAR2026
Subject information and informed consent form (for publication) L1_ SIS and ICF Main Study_For Publication 1.2
Subject information and informed consent form (for publication) L1_ SIS and ICF Main_Clean_For Publication 2.1
Subject information and informed consent form (for publication) L1_ SIS and ICF main_English_For Publication v7-11Mar2025 7.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Main_For Publication 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Main_redacted 3.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Pharmacogenetic Lithuanian - For Publication 11MAY2023
Subject information and informed consent form (for publication) L1_ SIS and ICF Pharmacogenetic research FP 6.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Pharmacogenetic research FP 5.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Pharmacogenetic Research_For Publication 2.1
Subject information and informed consent form (for publication) L1_ SIS and ICF Pharmacogenetic Russian - For Publication 11MAY2023
Subject information and informed consent form (for publication) L1_ SIS and ICF Pharmacogenetic Sub-study For Publication 1.1
Subject information and informed consent form (for publication) L1_ SIS and ICF Pharmacogenetics Clean_For Publication 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Power Of Attorney For Publication 4
Subject information and informed consent form (for publication) L1_ SIS and ICF Pregnancy Female_Clean_For Publication 1.1
Subject information and informed consent form (for publication) L1_ SIS and ICF Pregnancy Female_For Publication 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Pregnancy Male_Clean_For Publication 1.1
Subject information and informed consent form (for publication) L1_ SIS and ICF Pregnancy Male_For Publication 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Reimbursement Payment FP 5.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Reimbursement through Greenphire FP 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Withdrawal Options 2.1
Subject information and informed consent form (for publication) L1_ SIS and ICF Withdrawal_For Publication 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Biomarker and Future research_FP 4.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Breastfeeding_FP 1
Subject information and informed consent form (for publication) L1_ SIS and ICF_Female Participant_FP 1
Subject information and informed consent form (for publication) L1_ SIS and ICF_GDPR_FP 4.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_ICF Future Research_For Publication 2.2
Subject information and informed consent form (for publication) L1_ SIS and ICF_ICF Main_For Publication 6.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_ICF Payment Reimbursement_For Publication 3.2
Subject information and informed consent form (for publication) L1_ SIS and ICF_ICF Pharmakogenetic_For Publication 2.2
Subject information and informed consent form (for publication) L1_ SIS and ICF_Informed Consent Procedure form Austria 1
Subject information and informed consent form (for publication) L1_ SIS and ICF_Informed Consent Procedure France_For Publication 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Main ICF_For Publication 8.1
Subject information and informed consent form (for publication) L1_ SIS and ICF_Main Study_Clean_For Publication 5.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Pharmacogenetic_FP 4.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Pregnant Partner_FP 1
Subject information and informed consent form (for publication) L1_ICF Alternate Visits For Publication 3
Subject information and informed consent form (for publication) L1_ICF Alternate visits Site Hjartamidstodin For Publication 3.1
Subject information and informed consent form (for publication) L1_ICF Main Site Hjartamidstodin For Publication 23JAN2026
Subject information and informed consent form (for publication) L1_ICF Pharmacogenetic Site Hjartamidstodin For Publication 3.1
Subject information and informed consent form (for publication) L1_ICF_EN_For Publication 5.0
Subject information and informed consent form (for publication) L1_ICF_FR_For Publication 5.0
Subject information and informed consent form (for publication) L1_ICF_NL_For Publication 5.0
Subject information and informed consent form (for publication) L1_Informed consent form Main_For Publication 7.0
Subject information and informed consent form (for publication) L1_Informed consent form Main_Translation_For Publication 7.0
Subject information and informed consent form (for publication) L1_Informed Consent Procedure 1
Subject information and informed consent form (for publication) L1_Informed consent procedure_20180244_FP 1
Subject information and informed consent form (for publication) L1_SIS and ICF Biomarkers and future research_For Publication 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF Clincard_For Publication 3.2
Subject information and informed consent form (for publication) L1_SIS and ICF Exceptional Epidemiological Measures_For Publication 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF Information Leaflet Finnish For Publication 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main For Publication 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main Legal Representative Norwegian_For Publication 30MAR2026
Subject information and informed consent form (for publication) L1_SIS and ICF Main NL_For Publication 6.3
Subject information and informed consent form (for publication) L1_SIS and ICF Main NL_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main Norwegian_For Publication 30MAR2026
Subject information and informed consent form (for publication) L1_SIS and ICF main_Bulgarian_For Publication v7-11Mar2025 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_For Publication 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pharmacogenetics_For Publication 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnancy follow up program Father 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnancy follow up program Mother 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnancy man_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnancy woman_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Withdrawal_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Alternate Visits_for publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF_Alternative visits_Estonian_for publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF_Alternative visits_Russian_for publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF_BMFR_Estonian_for publication 23MAR2023
Subject information and informed consent form (for publication) L1_SIS and ICF_BMFR_Russian_for publication 23MAR2023
Subject information and informed consent form (for publication) L1_SIS and ICF_FR substudy_For publication 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Study_For Publication 4.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Enrolled_For Publication 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Estonian_for publication 19JAN2026
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_For publication 23JAN2026
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_FP 8.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_New p._For Publication 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Russian_for publication 19JAN2026
Subject information and informed consent form (for publication) L1_SIS and ICF_PG substudy_For publication 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pharmacogenetic_Estonian_for publication 23MAR2023
Subject information and informed consent form (for publication) L1_SIS and ICF_Pharmacogenetic_For publication 24NOV2022
Subject information and informed consent form (for publication) L1_SIS and ICF_Pharmacogenetic_Russian_for publication 23MAR2023
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Participant ICF_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner ICF_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS_ICF_ Pregnancy Father Form_FP 1.2
Subject information and informed consent form (for publication) L1_SIS_ICF_Pregnancy Mother Form_father is participant_FP 1.2
Subject information and informed consent form (for publication) L1_SIS_ICF_Pregnancy Mother Form_mother is participant_FP 1.2
Subject information and informed consent form (for publication) L1_SIS-ICF_FR_Germany_FP 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Main_20180244_Germany_FP 6.1
Subject information and informed consent form (for publication) L1_SIS-ICF_PG_Germany_FP 2.0
Subject information and informed consent form (for publication) L2 Other subject information material Informed consent procedure For Publication 1
Subject information and informed consent form (for publication) L2_ Informed Consent Procedure 1
Subject information and informed consent form (for publication) L2_ Other subject information material Informed Consent Procedure - For Publication 2.0
Subject information and informed consent form (for publication) L2_ Other subject information material Informed Consent Procedure_FP 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material Patient card FP 1
Subject information and informed consent form (for publication) L2_ Other subject information material Patient card_FP 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material Your rights as a Subject in Clinical Trials For Publication 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Data Privacy Form For publication 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Informed Consent Procedure_FP 2.0
Subject information and informed consent form (for publication) L2_Informed consent procedure_for publication 1.0
Subject information and informed consent form (for publication) L2_Informed consent procedure_For Publication 1
Subject information and informed consent form (for publication) L2_Other subject information material Informed Consent Procedure For Publication 2
Subject information and informed consent form (for publication) L2_Other subject information material Informed Consent Procedure For Publication 1
Subject information and informed consent form (for publication) L2_Other subject information material Personal Data Processing Consent_For Publication Version 1.0 - 31.May
Subject information and informed consent form (for publication) L2_Other subject information material_GDPR_For publication 3.3
Subject information and informed consent form (for publication) L2_Other subject information material_IC Procedure_For Publication 1
Subject information and informed consent form (for publication) L2_Other subject information material_Informed consent procedure_for publication 1
Subject information and informed consent form (for publication) L2_Other subject information material_Informed Consent Procedure_For Publication 1
Subject information and informed consent form (for publication) L2_Other subject information material_List of Patient Materials_fp 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Card_For Publication 2.0
Subject information and informed consent form (for publication) L2_Other subject information material_Patient card_For publication 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Travel Agreement_For Publication 3.0
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Travel T and C_For Publication 3.0
Subject information and informed consent form (for publication) L2_other subject information material_pregnancy ICF_ENG_FP 1.5
Subject information and informed consent form (for publication) L2_other subject information material_pregnancy ICF_FR_FP 1.5
Subject information and informed consent form (for publication) L2_other subject information material_pregnancy ICF_NL_FP 1.5
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Subject information and informed consent form (for publication) L3_ICF Procedure_For Publication 1
Synopsis of the protocol (for publication) D1_ Protocol synopsis FR 2022-501608-85 20180244 FOR PUBLICATION 4
Synopsis of the protocol (for publication) D1_ Protocol synopsis IT full 2022-501608-85 20180244 FOR PUBLICATION 7
Synopsis of the protocol (for publication) D1_ Protocol synopsis LT 2022-501608-85 20180244 FOR PUBLICATION 4
Synopsis of the protocol (for publication) D1_ Protocol synopsis NO 2022-501608-85 20180244 FOR PUBLICATION 4
Synopsis of the protocol (for publication) D1_ Protocol synopsis PL 2022-501608-85 20180244 FOR PUBLICATION 4
Synopsis of the protocol (for publication) D1_ Protocol synopsis RO 2022-501608-85 20180244 FOR PUBLICATION 4
Synopsis of the protocol (for publication) D1_ Protocol synopsis SE 2022-501608-85 20180244 FOR PUBLICATION 4
Synopsis of the protocol (for publication) D1_ Protocol synopsis SK 2022-501608-85 20180244 FOR PUBLICATION 4
Synopsis of the protocol (for publication) D1_Full Protocol Synopsis_DE AT_2022-501608-85_20180244_For Publication 7
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BG_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_CZ_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_DE AT_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_DE_BE_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ENG_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ES_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_FR BE_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_Full_HU_2022-501608-85_20180244_For Publication 7
Synopsis of the protocol (for publication) D1_Protocol Synopsis_GR_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_HU_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_IS_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_IT_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_NL BE_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_NL_2022-501608-85_20180244_For Publication 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_PT_2022-501608-85_20180244_For Publication 4

Application history

23 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-12-09 Denmark Acceptable
2023-05-02
 2023-05-03
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-05-22 Acceptable
2023-05-02
 2023-05-22
3 SUBSTANTIAL MODIFICATION SM-1 2023-05-23 Acceptable 2023-06-08
4 SUBSTANTIAL MODIFICATION SM-2 2023-08-21 Denmark Acceptable
2023-10-02
 2023-10-03
5 SUBSTANTIAL MODIFICATION SM-3 2023-12-11 Denmark Acceptable
2024-03-25
 2024-03-25
6 NON SUBSTANTIAL MODIFICATION NSM-2 2024-08-06 Denmark Acceptable
2024-03-25
 2024-08-06
7 SUBSTANTIAL MODIFICATION SM-6 2024-09-30 Denmark Acceptable
2024-11-27
 2024-11-27
8 SUBSTANTIAL MODIFICATION SM-7 2025-01-29 Acceptable 2025-02-28
9 SUBSTANTIAL MODIFICATION SM-8 2025-01-31 Acceptable 2025-02-28
10 SUBSTANTIAL MODIFICATION SM-9 2025-02-03 Acceptable 2025-02-19
11 SUBSTANTIAL MODIFICATION SM-10 2025-03-24 Denmark Acceptable
2025-06-20
 2025-06-23
12 NON SUBSTANTIAL MODIFICATION NSM-3 2025-08-04 Acceptable
2025-06-20
 2025-08-04
13 NON SUBSTANTIAL MODIFICATION NSM-4 2025-08-22 Denmark Acceptable
2025-06-20
 2025-08-22
14 SUBSTANTIAL MODIFICATION SM-11 2025-08-29 Acceptable 2025-10-08
15 SUBSTANTIAL MODIFICATION SM-12 2025-08-29 Acceptable 2025-10-15
16 SUBSTANTIAL MODIFICATION SM-14 2025-09-05 Acceptable 2025-10-03
17 SUBSTANTIAL MODIFICATION SM-15 2025-09-11 Acceptable 2025-10-02
18 SUBSTANTIAL MODIFICATION SM-16 2025-09-17 Acceptable 2025-11-12
19 SUBSTANTIAL MODIFICATION SM-17 2025-10-09 Acceptable 2025-11-23
20 NON SUBSTANTIAL MODIFICATION NSM-5 2025-12-03 Acceptable 2025-12-03
21 NON SUBSTANTIAL MODIFICATION NSM-6 2025-12-11 Acceptable 2025-12-11
22 SUBSTANTIAL MODIFICATION SM-18 2026-02-06 Denmark Acceptable
2026-04-24
 2026-04-24
23 NON SUBSTANTIAL MODIFICATION NSM-7 2026-05-13 Acceptable
2026-04-24
 2026-05-13

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