Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
8,323
Countries
20
Sites
296
Cardiovascular Disease
The primary objectives of this study is to demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with establis…
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 6 Mar 2020 → ongoing
- Decision date (initial)
- 2024-05-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2023-508292-37-00
- EudraCT number
- 2019-001076-11
- ClinicalTrials.gov
- NCT04023552
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Pharmacogenetic, Efficacy, Pharmacokinetic, Safety
The primary objectives of this study is to demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL.
Secondary objectives 4
- Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal stroke.
- Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, non-fatal MI and urgent coronary re-vascularization requiring hospitalization.
- Evaluate the rate of all cause death.
- Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in lowering the Lp(a) level at 1 year.
Conditions and MedDRA coding
Cardiovascular Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10051614 | Arteriosclerotic cardiovascular disease | 10047065 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Lp(a) ≥ 70 mg/dL at the screening visit
- Optimal LDL-cholesterol lowering treatment
- Myocardial infarction: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
- Ischemic stroke: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
- Clinically significant symptomatic peripheral artery disease
Exclusion criteria 8
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a population of patients with elevated Lp(a) ≥ 70 mg/dL
- Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a subpopulation of patients with elevated Lp(a) ≥ 90 mg/dL
Secondary endpoints 4
- Time to the first occurrence of the CEC confirmed composite endpoint of MACE (CV death, non-fatal MI, and non-fatal stroke)
- Time to the first occurrence of the CEC confirmed composite endpoint of CHD: CHD death, non-fatal MI, urgent coronary revascularization requiring hospitalization
- Change in Lp(a) in the log scale from baseline at 1 year
- Time to CEC confirmed all-cause death
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10213050 · Product
- Active substance
- Pelacarsen
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 6000 mg milligram(s)
- Max treatment duration
- 75 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 33
| Organisation | City, country | Duties |
|---|---|---|
| Eco-Abc Sp. z o. o. ORG-100046253
|
Belchatow, Poland | Other |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Jumo Health USA Inc. ORG-100044054
|
New Haven, United States | Other |
| Statmed Sp. z o.o. ORG-100047187
|
Golkow, Poland | Other |
| S & D Pharma Logistics BG EOOD ORG-100017521
|
Sofia, Bulgaria | Other |
| Kayentis ORG-100037894
|
Meylan, France | E-data capture |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring |
| Phardis S.r.l. ORG-100019559
|
Calvenzano, Italy | Other |
| Distica hf. ORG-100022309
|
Gardabaer, Iceland | Other |
| Specific Pharma A/S ORG-100015041
|
Copenhagen Sv, Denmark | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Other |
| Movianto Belgium ORG-100012072
|
Aalst, Belgium | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Abf Pharmaceutical Services GmbH ORG-100014752
|
Vienna, Austria | Other |
| Opt-X-Pense Kft. ORG-100047138
|
Budaors, Hungary | Other |
| World Courier Bulgaria EOOD ORG-100050062
|
Sofia, Bulgaria | Other |
| Alliance Healthcare Romania S.R.L. ORG-100034371
|
Rudeni, Romania | Other |
| Freja Transport & Logistics AS ORG-100018845
|
Frogner, Norway | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Qualitymetric Incorporated LLC ORG-100044132
|
Johnston, United States | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Other |
| Mag. Andreas Raffeiner GmbH ORG-100043223
|
Walding, Austria | Code 8 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Interactive response technologies (IRT) |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| ADR Logistics Kft. ORG-100045267
|
Budaors, Hungary | Other |
| Opis S.r.l. ORG-100011127
|
Desio, Italy | Other |
| Oriola Sweden AB ORG-100011733
|
Molnlycke, Sweden | Code 14 |
| Movianto Slovensko s.r.o. ORG-100020628
|
Senec, Slovakia | Other |
| Eurofins Genomics Europe Applied Genomics GmbH ORG-100044499
|
Ebersberg, Germany | Other |
| SALUS Veletrgovina druzba za promet s farmacevtskimi medicinskimi in drugimi proizvodi d.o.o. ORG-100017689
|
Ljubljana, Slovenia | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
Locations
20 EU/EEA countries · 296 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 120 | 6 |
| Belgium | Ongoing, recruitment ended | 93 | 8 |
| Bulgaria | Ongoing, recruitment ended | 48 | 8 |
| Czechia | Ongoing, recruitment ended | 506 | 39 |
| Denmark | Ongoing, recruitment ended | 183 | 7 |
| France | Ongoing, recruitment ended | 84 | 13 |
| Germany | Ongoing, recruitment ended | 1,019 | 56 |
| Greece | Ongoing, recruitment ended | 50 | 8 |
| Hungary | Ongoing, recruitment ended | 138 | 15 |
| Iceland | Ongoing, recruitment ended | 50 | 2 |
| Italy | Ongoing, recruitment ended | 190 | 22 |
| Netherlands | Ongoing, recruitment ended | 662 | 25 |
| Norway | Ongoing, recruitment ended | 52 | 2 |
| Poland | Ongoing, recruitment ended | 125 | 11 |
| Portugal | Ongoing, recruitment ended | 48 | 3 |
| Romania | Ongoing, recruitment ended | 48 | 10 |
| Slovakia | Ongoing, recruitment ended | 239 | 37 |
| Slovenia | Ongoing, recruitment ended | 60 | 2 |
| Spain | Ongoing, recruitment ended | 365 | 19 |
| Sweden | Ongoing, recruitment ended | 37 | 3 |
| Rest of world
Russian Federation, Peru, Turkey, China, Switzerland, Australia, India, United States, Brazil, Japan, Guatemala, Israel, Taiwan, South Africa, United Kingdom, Colombia, Mexico, Argentina, Chile, Hong Kong, Korea, Republic of, Canada
|
— | 4,206 | — |
Investigational sites
Konvent Der Barmherzigen Brueder
#3006, Seilerstaette 2, 4020, Linz
Medizinische Universitaet Innsbruck
#3004: Department Innere Medizin, Univ.-Klinik für Innere Medizin I, Anichstrasse 35, 6020, Innsbruck
Krankenhaus Nord Klinik Floridsdorf
#3001: Abteilung für Kardiologie, Bruenner Strasse 68, Floridsdorf, Vienna
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
#3003: Univ.-Klinik Innere Medizin I, Gastroenterologie und Hepatologie, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University Of Vienna
#3005: Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Graz
#3002: Univ.-Klinik Innere Medizin, Klinische Abteilung für Endokrinologie und Diabetologie, Neue Stiftingtalstrasse 6, 8010, Graz
Az St-Jan Brugge-Oostende A.V.
#3060: Cardiology, Ruddershove 10, 8000, Brugge
Algemeen Ziekenhuis Groeninge
#3061: Cardiology, President Kennedylaan 4, 8500, Kortrijk
Ziekenhuis Oost Limburg
#3058: Cardiology, Synaps Park 1, 3600, Genk
Centre Hospitalier Régional de Huy
#3059: Cardiology, Rue des Trois Ponts 2, 4500, Huy
O.L.Vrouw van Troost
#3056: Cardiology, Kroonveldlaan 50, 9200, Dendermonde
Hopital Erasme
#3051: Cardiology, Lennikse Baan 808, 1070, Anderlecht
A.Z. Sint-Maarten
#3057: Cardiology, Liersesteenweg 435, 2800, Mechelen
Azorg
3052: Cardiology, Moorselbaan 164, 9300, Aalst
Diagnostic And Consulting Center St. Georgi Pobedonosetc EOOD
#3123, Ul. Vanche Mihaylov 1, 8000, Burgas
Medicinski Centar Hipokrat-N EOOD
#3124, Bulgaria Blvd 61, Fl 2 Fl 1 Fl 3, Plovdiv
University Multiprofessional Hospital For Active Treatment Kanev AD
#3121:Department of Cardiology, Ulitsa Tsirkovna Nezavisimost 2, 7000, Ruse
Multiprofile Hospital For Active Treatment Blagoevgrad AD
#3109:Department of Cardiology, Ulitsa Slavyanska 60, 2700, Blagoevgrad
Мultidisciplinary hospital for active treatment Saint George Pernik OOD
#3108:Department of Cardiology, Ulitsa Sveti Kiril I Metodiy 77, 2300, Pernik
University Hospital St. Anna
#3102:Clinic of internal diseases, Ulitsa Dimitir Mollov 1, 1750, Sofiya
Medical Center Medconsult Pleven OOD
#3119, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
National Multidisciplinary Transport Hospital Tsar Boris III
#3101:Clinic of Cardiology, Bulevard Knyaginya Mariya Luiza 104, 1233, Sofia
VASOMED Clinic s.r.o.
3158:Kardiologie, Chittussiho 1001/9, Slezska Ostrava, Ostrava
Clinical Trials Service s.r.o.
3169:Kardiologie, Masarykovo Namesti 155, 686 01, Uherske Hradiste
PreventaMed s.r.o.
#3196:Kardiologie, Domovina 774/2, 779 00, Olomouc
Kardio CZ s.r.o.
#3160:Kardiologická ambulance, Revolucni 456/28, Usti Nad Labem-Centrum, Usti Nad Labem-Mesto
Angiologicka ambulance s.r.o.
#3174:Angiologická ambulance, Cs. Armady 12c/2052, 748 01, Hlucin
Kardiologie MUDr. Jiří Kuchař
#3181:Kardiologie, T.G. Masaryka 187, 381 01, Český Krumlov
Cévní ambulance MATMED, s.r.o., MediCentrum Hodonín
#3175:Cévní ambulance, Kollárova 9, 695 01, Hodonín
Univmed s.r.o.
#3172:Kardiologie, Studentska 812/6, Bohunice, Brno-Bohunice
Kromerizska nemocnice a.s.
#3170:Interní oddělení, Havlickova 660/69, 767 01, Kromeriz
Kardiologická ambulance
#3168:Kardiologická ambulance, J. A. Komenského 3423/1c, 434 01, Most
Angionika s.r.o.
#3199:Kardiologie, Fibichova 586, 252 64, Velke Prilepy
Corintez s.r.o.
#3157:Interna a Kardiologie, Seydlerova 2451/8, Stodulky, Prague 13
KardioBusak s.r.o.
#3171:Interní a kardiologická ambulance, Kosmonautu 2303, 440 01, Louny
Kardio Chlumec s.r.o.
#3193:Kardiologie, Nadrazni 783, 503 51, Chlumec Nad Cidlinou Iv
Nemocnice Pardubickeho kraje a.s.
#3159:Interní klinika-Kardiologické odd, Kyjevska 44 Pardubicky, 530 03, Pardubice
Kardiologie Vinohrady s.r.o.
#3198:Kardiologie, Vodickova 1935/38, Nove Mesto, Prague 1
Pro-Cardio s.r.o.
#3166:Kardiologie, Vzdusna 1373/12, Liberec I-Stare Mesto, Liberec
Kardiologicka a interni ambulance Liberec s.r.o.
#3191:Kardiologická a interní ambulance, Klasterni 117/2, Liberec V-Kristianov, Liberec
Policska nemocnice s.r.o.
#3192:Interní ambulance, Eimova 294 Horni Predsmesti, 572 01, Policka
Fakultni Nemocnice Brno
#3190:Interní kardiologická klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice U Sv Anny V Brne
#3184:Kardiologie, Pekarska 53, Stare Brno, Brno-Stred
Hospital Jihlava
#3176:Kardiologické oddělení, Vrchlickeho 59, 586 01, Jihlava 1
Pedicor Care s.r.o.
#3155:Angiologická ambulance, Horni 266/73, Dubina, Ostrava
Kardiologicka ambulance MUDr. Ferkl s.r.o.
#3173:Kardiologická ambulance, Palackeho 201, 541 01, Horni Predmesti
AGEL Stredomoravska nemocnicni a.s.
#3180:Interní oddělení, Dvorakova 75, 751 52, Prerov
Oblastni nemocnice Kolin a.s. nemocnice Stredoceskeho kraje
#3152:Interní oddělení, Zizkova 146, 280 02, Kolin III
Cardio Research s.r.o.
#3194:Kardiologie, J. A. Bati 5645, 760 01, Zlin
Edumed s.r.o.
#3167:Kardiologie, Smetanova 91, 550 01, Broumov
InterKardioML s.r.o.
#3161:Kardiologie, Krizikova 715/9, 353 01, Marianske Lazne
Kardio s.r.o.
#3165:Kardiologie, Vltavinskla 1289, 674 01, Trebic
MUDr. MICHALÍK s.r.o.
#3188:Kardiologie, Výškovická 165/126, 700 30, Ostrava- Zábřeh
Nemocnice AGEL Valasske Mezirici a.s.
#3189:Kardiologická ambulance, U Nemocnice 980, 757 01, Valasske Mezirici
Nemocnice Pardubickeho kraje a.s.
#3154:Kardiologie, Kollarova 2070/22, Predmesti, Svitavy
Medicus Services s.r.o.
#3156:Kardiologie, Nadrazni 1317/5, 250 01, Brandys Nad Labem
Vseobecna Fakultni Nemocnice V Praze
#3151:Centrum preventivní kardiologie, Karlovo Namesti 554/32, Nove Mesto, Prague 2
Mte spol. s r.o.
#3178:Kardiologická ambulance, Hybesova 289/43, Stare Brno, Brno 2
Benedor s.r.o.
#3163:Kardiologická, interní a cévní ambulance, 39, Opavska 962, Pustkovec
Avicena Kardiologie Interna s.r.o.
#3179:Kardiologie, Na Struze 230/6, Nove Mesto, Prague
Kardio Melnik s.r.o.
#3195:Kardiologie, Bezrucova 605/14, 276 01, Melnik
Esbjerg Sygehus
#3203: Hjertemedicinsk projektafdeling E3, Finsensgade 35, 6700, Esbjerg
Herlev Hospital
#3201: Klinisk Biokemisk afdeling. Klinisk Biokemisk, Forskning, Borgmester Ib Juuls Vej 31, 2730, Herlev
Region Midtjylland
#3202: Hjertemedicinsk forskning, Lipid klinik, Heibergs Alle 5a, 8800, Viborg
Region Sjaelland
#3205: Kardiologisk Afdeling - Kardiologisk Forsknings Enhed, Sygehusvej 10, 4000, Roskilde
Rigshospitalet
#3207: Hjertemedicinsk Klinik, KFE 9631; Blegdamsvej 58, opg. 96, 3 sal., Blegdamsvej 9, 2100, Copenhagen Oe
Aarhus Universitetshospital
#3206: Hjertesygdomme, Klinisk Forskning, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
#3204: Hjertemedicinsk afdeling, Hjertemedicinsk Forskningsenhed, Hospitalsbyen 1, 9260, Gistrup
Centre Hospitalier Universitaire De Lille
#3304:Cardiology, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hospices Civils De Lyon
#3323:Cardiology, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Assistance Publique Hopitaux De Paris
#3305:Cardiology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Polyclinique Vauban
#3322:Cardiology, 10 Avenue Vauban, 59300, Valenciennes
Centre Hospitalier De Tourcoing
#3303:Cardiology, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Centre Hospitalier Intercommunal Compiegne Noyon
#3332:Cardiology, 8 Avenue Henri Adnot, 60200, Compiegne
Assistance Publique Hopitaux De Paris
#3307:Cardiology, 20 Rue Leblanc, 75015, Paris
Les Hopitaux De Chartres
#3317:Cardiology, 4 Rue Claude Bernard, 28630, Le Coudray
Centre Hospitalier Universitaire De Toulouse
#3306:Cardiology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire Grenoble Alpes
#3318:Cardiology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Regional Universitaire De Tours
#3301:Cardiology, Avenue De La Republique, 37170, Chambray Les Tours
Hopital Saint Antoine
#3309:Cardiology, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Universitaire De Nantes
#3333:Endocrinology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Medizentrum Essen Borbeck
#3445, Huelsmannstrasse 6, Borbeck, Essen
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
#3474: Klinik für Allgemeine und Interventionelle Kardiologie / Angiologie, Georgstrasse 11, Innenstadt, Bad Oeynhausen
Klinik am See
#3460: Klinik für Innere Medizin / Kardiologie, Seebad 84, 15562, Rüdersdorf bei Berlin
Kath. St. Paulus GmbH
#3462:Klinik für Innere Medizin I, Johannesstrasse 9-17, Mitte, Dortmund
Praxis Herznah Dr. med. Prohaska und Dr. med. Schulte
#3454, Schlüsselbergstr. 6, 84453, Mühldorf am Inn
Kardiologische Praxis Karl-Heinz Schermaul
#3498, Robert-Siewert-Strasse 32, 09122, Chemnitz
Gemeinschaftspraxis Ruhr – Praxis Überruhr
#3492, Schaffelhofer Weg 10, 45277, Essen
Kliniken Nordoberpfalz AG
#3409: Medizinische Klinik II, Soellnerstrasse 16, Scheibe, Weiden I D Opf
Praxis Dr. Frank Menzel
#3411, Puschkinallee 17, 06846, Dessau-Roßlau
Gemeinschaftspraxis für Kardiologie und Pneumologie
#3450, Moellendorfstr. 111, 10367, Berlin
Kardiologische Gemeinschaftspraxis Am Park Sanssouci
#3480, Zimmerstrasse 7a, Brandenburger Vorstadt, Potsdam
Praxis für Innere Medizin / Kardiologie
#3456, Dresdner Str. 37, 01662, Meißen
Medical Center - University Of Freiburg
#3484: Universitäts-Herzzentrum Campus Bad Krozingen, Klinik für Kardiologie und Angiologie II, Suedring 15, 79189, Bad Krozingen
Gemeinschaftspraxis Dr. Biesenbaum / Dr. Gerbaulet
#3451, Goethestr. 1, 32584, Löhne
Klinikum Bielefeld gGmbH
#3408: Klinik für Kardiologie und internistische Intensivmedizin, Teutoburger Strasse 50, Innenstadt, Bielefeld
Charite Universitaetsmedizin Berlin KöR
#3437: Medizinische Klinik für Kardiologie, Hindenburgdamm 30, Lichterfelde, Berlin
Studienambulanz Dr. Schubert
#3453, Bautzmannstr. 6, 04315, Leipzig
Herzzentrum Dresden GmbH Universitaetsklinik
#3418: Klinik für Innere Medizin und Kardiologie, Fetscherstrasse 76, Johannstadt-Nord, Dresden
Universitaetsklinikum Muenster AöR
#3512: Medizinische Klinik D, Lipidambulanz, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Uhz Klinische Forschung
#3405, Unterstrasse 75, Frintrop, Essen
Cardiologicum Hamburg GbR
#3441, Schlossstrasse 12, Marienthal, Hamburg
Zentrum für Klinische Studien
#3493, Hauptstrasse 98, 66386, St. Ingbert
University Hospital Cologne AöR
#3403: Poliklinik für Endokrinologie, Diabetologie und Präventivmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Kardiologische Gemeinschaftspraxis
#3428, Collegienstrasse 76, 06886, Lutherstadt-Wittenberg
Josephs-Hospital Warendorf
#3481, Am Krankenhaus 2, 48231, Warendorf
Klinische Forschung Dresden GmbH
#3402, Prager Strasse 10, Seevorstadt-Ost/Grosser Garten, Dresden
Universitaetsklinikum Aachen AöR
#3472: Medizinische Klinik I, Pauwelsstrasse 30, 52074, Aachen
Kardiologische Praxis im Spreebogen
#3412, Alt Moabit 101b, 10559, Berlin
Kardiologische Praxis Dr. med Wolfgang Jungmair
#3436, Louisenstraße 63, 61348, Bad Homburg
Studienzentrum Bocholder Straße
#3443, Bocholder Strasse 158, 45355, Essen
SKP-Studienzentrum der kardiologischen Praxisgemeinschaft Rankestrasse GmbH
#3510, Rankestrasse 34, Charlottenburg, Berlin
Goethe University Frankfurt
#3508: Medizinische Klinik III Kardiologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Charite Universitaetsmedizin Berlin KöR
#3401:Campus Virchow Klinikum, Augustenburger Platz 1, Wedding, Berlin
Praxis Dr. med. Nicole Toursarkissian
#3483, Heinz-Galinski-Strasse 1, 13347, Berlin
ClinPhenomics CVC GmbH
#3507, Schaumainkai 101-103, Sachsenhausen, Frankfurt Am Main
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen
#3430: Deutsches Herzzentrum München, Lazarettstrasse 36, Neuhausen-Nymphenburg, Munich
Gemeinschaftspraxis für Innere Medizin und Diabetologie
#3413, Beselerstrasse 2a, 22607, Hamburg
B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH
#3417, Bergmannstrasse 28, Wehlheiden, Kassel
Universitaetsklinikum Mannheim GmbH
#3494, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
CIMS Studienzentrum Bamberg GmbH
#3435, Buger Strasse 82, Berg, Bamberg
Klinische Forschung Hannover-Mitte GmbH
#3489, Schillerstrasse 30, Mitte, Hanover
Velocity Clinical Research GmBH
#3440, Ansbacher Strasse 17-19, Schoeneberg, Berlin
MVZ am Kuechwald GmbH ambulantes HerzCentrum
#3475, Buergerstrasse 2, Schlosschemnitz, Chemnitz
ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH Mannheim
#3465, Georg-Lechleiter-Platz 3, Schwetzingerstadt, Mannheim
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
#3446: Universitätstudienzentrum für Stoffewchselerkrankungen, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Praxis für Innere Medizin
#3470, Himmelreichallee 37-41, 48149, Muenster
St. Vinzenz-Hospital GmbH
#3423: Innere Medizin III - Kardiologie, Merheimer Strasse 221-223, Nippes, Cologne
Studienzentrum Herzklinik Ulm MVZ
#3414, Magirusstrasse 49, 89077, Ulm
Universitaetsklinikum Leipzig AöR
#3438: Klinik und Poliklinik für Kardiologie / Haus 4, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
#3421: Studienzentrum, Haus A, Enderstrasse 59, Dresden
Universitaetsklinikum Magdeburg AöR
#3463: Institut für Klinische Chemie und Pathobiochemie HS39, Leipziger Strasse 44, 39120, Magdeburg
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
#3426, Forststrasse 3, Radeberger Vorstadt, Dresden
Universitaetsklinikum Jena KöR
#3488: Klinik für Innere Medizin I, Lipidambulanz, Am Klinikum 1, Lobeda, Jena
Klinikum der Universitaet Muenchen AöR
#3442: Medizinische Klinik und Poliklinik IV / Stoffwechselambulanz / Lipidapharese, Ziemssenstrasse 5, 80336, Munich
Praxis Oedeme
#3490, Auf der Hoehe 69, 21339, Lueneburg
MVZ Diabeteszentrum Dr. Tews GmbH
3427, Herzbachweg 14e, 63571, Gelnhausen
General University Hospital Of Larissa
#3560: Internal Medicine Clinic, P. O. Box 1425, 411 10, Larissa
University General Hospital Of Ioannina
#3558: 2nd University Internal Medicine Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
General Hospital of Chalkida
#3557: 2nd Cardiology Clinic, Vathrovouni, 34100, Chalcis
General University Hospital Of Larissa
#3559: Cardiology Clinic, P. O. Box 1425, 411 10, Larissa
Athens Naval Hospital
#3551: Cardiology Clinic, Dinokratous 70, 115 21, Athens
Hippokration Hospital
#3556: 1st Cardiology Clinic, Vassilissas Sofias Avenue 114, 115 27, Athens
University General Hospital Of Thessaloniki Ahepa
#3552: Cardiology Clinic, 1st St Kiriakidis Str, 546 36, Thessaloniki
General Hospital Of Nea Ionia Konstantopouleio Patision
#3553: Cardiology Clinic, Konstadopoulou Th. 3-5, 142 33, Nea Ionia
Medifarma-98 Kft.
3624: Kardiologiai Szakrendeles, Praga Utca 9, 4400, Nyiregyhaza
Semmelweis University
3601: Varosmajori Sziv- es Ergyogyaszati Klinika, Varosmajor Utca 68, Kerulet, Budapest XII
Kistarcsai Flor Ferenc Korhaz
3610: Neurologia es Stroke Osztaly, Semmelweis Ter 1, 2143, Kistarcsa
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
3620: I. Belgyogyaszat Kardiologia, Szentpeteri Kapu 72-76, 3526, Miskolc
University Of Pecs
3603: Szivgyogyaszati Klinika, Ifjusag Utja 13, 7624, Pecs
University Of Szeged
3605: Csaladorvosi Intezet, Tisza Lajos Korut 109, 6725, Szeged
University Of Debrecen
3621: Belgyogyaszati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
3604: II. Belgyogyaszat, Seregelyesi Ut 3, 8000, Szekesfehervar
Bajai Szent Rokus Korhaz
3609: Neurologia, Rokus Utca 10, 6500, Baja
Budapesti Uzsoki Utcai Korhaz
3618: Kardiologia, Uzsoki Utca 29-41, 1145, Budapest XIV
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
3602: I Belgyogyaszti Osztaly, Nagyvarad Ter 1, 1097, Budapest Ix
University Of Pecs
3614: Neurologiai Klinika, Ifjusag Utja 13, 7624, Pecs
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet
3615: I. Belgyogyaszati Osztaly - Kardiologia es Angiologia, Koves Ut 1, 1204, Budapest
Csongrad-Csanad Megyei Egeszseguegyi Ellato Koezpont Hodmezovasarhely-Mako
3619: Belgyogyaszat, Dr. Imre Jozsef Utca 2, 6800, Hodmezovasarhely
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
3607: III Belgyogyaszat, Szent Istvan Utca 68, 4400, Nyiregyhaza
Landspitali
#3802: Dept.Cardiology, 10D, Hringbraut 101, 101, Reykjavik
Hjartamidstoedin ehf.
#3801: Hjartamidstodin, Holtasmari 1, 201, Kopavogur
Azienda Ospedaliera Universitaria Federico II Di Napoli
#3677:UOSD Medicina Interna ed Emocoagulazione, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
#3661:U.O. di Medicina Interna, Via Pietro Albertoni 15, 40138, Bologna
Careggi University Hospital
#3657:S.O.D. Malattie Aterotrombotiche, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
#3653:U.O.C. Cardiologia 1, Piazza Oms 1, 24127, Bergamo
Istituto San Raffaele
#3658:Unità Cardio Metabolica e Trials Clinici, Via Olgettina 58, 20132, Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
#3680:Dipartimento di Medicina Traslazionale e di Precisione, Viale Del Policlinico 155, 00161, Rome
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
#3667:U.O.C. di Cardiologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero-Universitaria Sant Andre
#3656:U.O.C. di Cardiologia, Via Di Grottarossa 1035-1039, 00189, Rome
Hospital Santa Maria Della Misericordia
#3662:S.C. Medicina Interna, Piazzale Giorgio Menghini 1, 06129, Perugia
ASST Grande Ospedale Metropolitano Niguarda
#3651:S.C. Cardiologia 4, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Neurologico Mediterraneo Neuromed S.p.A.
#3659:U.O.C. di Angio-Cardio-Neurologia e Medicina Traslazionale, Via Atinense N. 18, 86077, Pozzilli
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
#3655:U.O.C. Astanteria - Medicina e Chirurgia d'Accettazione e d'Urgenza, Via Del Vespro 129, 90127, Palermo
I.N.R.C.A. Istituto Nazionale Di Riposo E Cura Per Gli Anziani
#3666:UOC Clinica Medica e Geriatrica, Via Della Montagnola 81, 60127, Ancona
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
#3671:S.C. di Cardiologia, Largo Citta' D'ippocrate 1, 84131, Salerno
Humanitas Research Hospital
#3669:U.O. di Cardiologia, Via Alessandro Manzoni 56, 20089, Rozzano
Universita' Degli Studi Di Ferrara
#3663:Centro Scompenso Cardiaco U.O. Cardiologia (Studi medici 1B2), Via Aldo Moro 8, 44124, Ferrara
Azienda Ospedaliero Universitaria Pisana
#3672:U.O. Cardiologia 1, Via Paradisa 2, 56124, Pisa
Istituto Auxologico Italiano IRCCS
#3665:U.O. di Cardiologia, Piazzale Brescia 20, 20149, Milan
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
#3674:UOC Medicina Generale, Viale Luigi Borri 57, 21100, Varese
Fondazione Toscana Gabriele Monasterio
#3681:U.O.S.V.D. Lipoaferesi e Centro di Riferimento Reg per le Dislipidemie Ereditarie, Via Giuseppe Moruzzi 1, 56124, Pisa
ASST Grande Ospedale Metropolitano Niguarda
#3668:S.S.D. Diagnosi e Cure Territoriali per le Malattie Cardiache, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Centro Cardiologico Monzino S.p.A.
#3676:Unità di Prevenzione dell'Aterosclerosi c/o CCM2, Via Carlo Parea 4, 20138, Milan
Leids Universitair Medisch Centrum (LUMC)
#3713: Cardiology, Albinusdreef 2, 2333 ZA, Leiden
Meander Medisch Centrum
#3707: Cardiology, Maatweg 3, 3813 TZ, Amersfoort
Stichting Martini Ziekenhuis
#3716: Cardiology, Van Swietenplein 1, 9728 NT, Groningen
Reinier de Graaf Groep
#3722: Cardiology, Reinier De Graafweg 5, 2625 AD, Delft
Alrijne Zorggroep Stichting
#3718: Cardiology, Simon Smitweg 1, 2353 GA, Leiderdorp
Radboud universitair medisch centrum / RADBOUDUMC
#3712: Cardiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Gelre Hospitals
#3715: Cardiology, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Spaarne Gasthuis
#3708: Cardiology, Boerhaavelaan 22, 2035 RC, Haarlem
Isala Klinieken Stichting
#3726: Cardiology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Deventer Ziekenhuis
#3705: Cardiology, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Zuyderland Medisch Centrum Stichting
#3719: Cardiology, Henri Dunantstraat 5, 6419 PC, Heerlen
Universitair Medisch Centrum Utrecht
#3709: Cardiology, Heidelberglaan 100, 3584 CX, Utrecht
Stichting Viecuri Medisch Centrum voor Noord-Limburg
#3711: Cardiology, Tegelseweg 210, 5912 BL, Venlo
Saxenburgh Medisch Centrum
#3721: Cardiology, Jan Weitkamplaan 4a, 7772 SE, Hardenberg
Groene Hart Ziekenhuis
#3717: Cardiology, Bleulandweg 10, 2803 HH, Gouda
Haga Hospital
#3710: Cardiology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Medisch Spectrum Twente
#3704: Cardiology, Koningsplein 1, 7512 KZ, Enschede
Noordwest Ziekenhuisgroep Stichting
#3702: Cardiology, Wilhelminalaan 12, 1815 JD, Alkmaar
Ziekenhuis Rivierenland
#3725: Cardiology, President Kennedylaan 1, 4002 WP, Tiel
OLVG Stichting
#3724: Cardiology, Oosterpark 9, 1091 AC, Amsterdam
Canisius Wilhelmina Hospital
#3703: Cardiology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Academisch Medisch Centrum
#3701: Cardiology, Meibergdreef 9, 1105 AZ, Amsterdam
Rijnstate Ziekenhuis Stichting
#3714: Cardiology, Wagnerlaan 55, 6815 AD, Arnhem
Elisabeth-Tweesteden Ziekenhuis
#3706: Cardiology, Dr. Deelenlaan 5, 5042 AD, Tilburg
D & A Research B.V.
#3723: Cardiology, Hegedyk 9, 8601 ZR, Sneek
Skedsmo Medisinske Senter AS
#3752, Presthagaveien 20, 2020, Skedsmokorset
Oslo University Hospital HF
#3754: Lipidklinikken, Trondheimsveien 235, 0586, Oslo
American Heart Of Poland S.A.
#3868: Polsko-Amerykańskie Kliniki Serca Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej, Swietego Andrzeja Boboli 20, 43-316, Bielsko-Biala
American Heart Of Poland S.A.
#3865: Małopolskie Centrum Sercowo-Naczyniowe PAKS, Ul. Topolowa 16, 32-500, Chrzanow
Centrum Medyczne Zdrowa J. Trebacz W. Zajdel Sp. j.
#3862, Ul. Zdrowa 1 Lok. 11, 31-216, Cracow
Uniwersyteckie Centrum Kliniczne
#3873: I Klinika Kardiologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Centrum Szybkiej Diagnostyki Kardiologicznej Kardiomed M. Zabowka E. Zabowka
#3861, ul. Lwowska 197, 33-100, Tarnów
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek. med. Krzysztof Cymerman
#3856, ul. Sucharskiego 2, 81-157, Gdynia
Centrum Zdrowia Metabolicznego Paweł Bogdański
#3852, ul. Nowina 14F, 60-589, Poznań
Specjalistyczna Praktyka Lekarska Ewa Mirek-Bryniarska
#3864, ul. Kazimierza Wielkiego 118, 30-082, Kraków
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
#3851: Odział Chorób Wewnętrznych Klinika Chorób Wewnętrznych i Farmakologii Klinicznej UM, Ul. Gen. Karola Kniaziewicza 1/5, 91-347, Lodz
Centrum Rehabilitacji i Kardiologii SOLUTARIS – Prokopczuk Sp.j.
#3855, ul. Gazowa 2b, 47-200, Kędzierzyn Koźle
Instytut Centrum Zdrowia Matki Polki
#3863:, Ul. Rzgowska 281/289, 93-338, Lodz
Unidade Local De Saude Do Alto Ave E.P.E.
#3902: Serviço de Cardiologia, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local De Saude Da Arrabida E.P.E.
#3903: Serviço de Cardiologia, Rua Camilo Castelo Branco, 2910-446, Setubal
Unidade Local De Saude De Coimbra E.P.E.
#3901: Serviço de Cardiologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
C.M.I. Cardiologie Dr. Mercea Corina Delia
#3955:Cardiology, Bd. Independentei 10/43 Punct de lucru:Strada Petre Dulfu nr.12A,Spatiu Comercial nr.1 Tronson Vest, 430124, Baia Mare
Cabinet Medical Individual Cardiologie- Dr. Pop Calin, Cabinet Cardiologie
#3953:Cardiology, Str. George Cosbuc 25A/2, 430222, Baia Mare
Clinica Medicala Data Plus S.R.L.
#3965:Internal Medicine, Strada Prof. Grigore Cobalcescu 35, 010192, Bucharest
Institutul de Boli Cardiovasculare Prof. Dr.George I.M. Georgescu, Iasi
#3970:Cardiology, Bd. Carol I nr. 50, 700503, Iasi
Spitalul Universitar De Urgenta Bucuresti
#3971:Cardiology, Splaiul Independentei 169, 050098, Bucharest
Medicali's S.R.L.
#3960:Cardiology, Strada Cernauti 13, 300362, Timisoara
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
#3972:Cardiology, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Cardiomed S.R.L.
#3954:Cardiology, Aleea Neculai Tudor C1, 700732, Jassi
Cardio Med S.R.L.
#3964:Cardiology, Strada Spania Nr 35a, 200513, Craiova
Mat Cord Biomedica S.R.L.
#3968:Cardiology, Strada Titulescu Nicolae 11, 120133, Buzau
Comcor s.r.o.
#4109: Kardiologická ambulancia, Rakocziho 3125, 945 01, Komarno
KaCH s.r.o.
#4108: Kardiologická ambulancia, Andovska 6, 940 02, Nove Zamky
Medicus plus s.r.o.
#4146: Ambulancia vnútorného lekárstva, Rozmarinova 20, 945 05, Komarno
Interna SK s.r.o.
#4162: Kardiologická ambulancia, Mudr. Pribulu 412/4, 089 01, Svidnik
Kruskamed s.r.o.
#4152: Kardiologická ambulancia a ambulancia vnútorného lekárstva, Levocska 6127/18, 080 01, Presov
Benimed s.r.o.
#4118: Kardiologická ambulancia, Javorova 2882/25, 921 01, Piestany
HeartCare s.r.o.
#4166: Kardiologická ambulancia, Tacevska 3998, 085 01, Bardejov
Medilex s.r.o.
#4155: Ambulancia vnútorného lekárstva, Zeleznicna 23, 979 01, Rimavska Sobota
Kardiocentrum Nitra s.r.o.
#4159: Kardiologická ambulancia IV, Spitalska 6, Stare Mesto, Nitra
Medipred s.r.o.
#4121: Kardiologická ambulancia, Sv. Jakuba 21, 085 01, Bardejov
Novamed spol. s r.o.
#4130: Kardiologická ambulancia, Bernolakova 10, Kralova, Banska Bystrica
University Hospital Bratislava
#4142: III. Interná klinika LF UK a UNB Interná ambulancia, Limbova 5, Nove Mesto, Bratislava
Národny ustav srdcovych a cievnych chorob a.s.
#4158: Oddelenie intervenčnej kardiológie, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
Nemocnica S Poliklinikou Brezno N.O.
#4104: Kardiologická ambulancia I., 273, Banisko 1, Brezno
Národny ustav srdcovych a cievnych chorob a.s.
#4144: Ambulantné oddelenie, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
Kardiomed Nz s.r.o.
#4124: Kardiologická ambulancia, L. Stura 18, 940 02, Nove Zamky
Medispektrum s.r.o.
#4117: Ambulancia vnútorného lekárstva, Gercenova 4/a, 851 01, Petrzalka
University Hospital Bratislava
#4106: Oddelenie neinvazívnej kardiológie, Antolska 11, Petrzalka, Bratislava
Kardio 1 s.r.o.
#4116: Kardiologická ambulancia, Námestie republiky 15., 984 01, Lučenec
DIAB s.r.o.
#4114: Ambulancia diabetológie a porúch látkovej premeny a výživy, Namestie 1. Maja 11, 048 01, Roznava
Medical group Kosice s.r.o.
#4111: Kardiologická ambulancia, Mudronova 29, Juh, Kosice
Intergal s.r.o.
#4143: Ambulancia vnútorného lekárstva, M. Culena 196/18, 038 43, Klastor Pod Znievom
Galenum s.r.o.
#4122: Ambulancia vnútorného lekárstva, Rajecka 1, Vrakuna, Bratislava
Zeleznicne zdravotnictvo Kosice s.r.o.
#4134: Ambulancia diabetológie a porúch látkovej premeny a výživy, Masarykova 9, Stare Mesto, Kosice
Fakultna Nemocnica Trnava
#4119: Interná klinika, Andreja Zarnova 11, 917 02, Trnava
Kardio-Sanus spol. s r.o.
#4161: Kardiologická ambulancia, Stefana Kralika 1 B, 841 07, Devinska Nova Ves
Medispol s.r.o.
#4112: Ambulancia vnutorného lekárstva, Konstantinova 17, 080 01, Presov
InterStom s.r.o.
#4123: Ambulancia vnútorného lekárstva, Cajkovskeho 2, Klokocina, Nitra
La Ro Cor s.r.o.
#4137: Kardiologická ambulancia, Snp 26, 972 51, Handlova
Národny ustav srdcovych a cievnych chorob a.s.
#4145: Oddelenie akútnej kardiológie - koronárnej starostlivosti, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
Medikard s.r.o.
#4113: Ambulancia vnútorného lekárstva, Jana Holleho 14/D, 080 01, Presov
Alian s.r.o.
#4120: Angiologická ambulancia, Sv. Jakuba 33, 085 01, Bardejov
Pentes s.r.o.
#4154: Kardiologická ambulancia, Halkova 3, 010 01, Zilina
Kardioamb s.r.o.
#4156: Kardiologická ambulancia, Petra Hostinskeho 4, 979 01, Rimavska Sobota
Fakultna Nemocnica Nitra
#4164: Interná klinika, Interná ambulancia, Spitalska 6, Stare Mesto, Nitra
CorArt s.r.o.
#4103: Kardiologická ambulancia, Nemocnicna 986/1, 017 01, Povazska Bystrica
Kardiomedina s.r.o.
#4138: Kardiologická ambulancia, Nemocnicna 1944/10, 026 01, Dolny Kubin
University Medical Center Ljubljana
#4592: Clinical Department of Cardiology, Zaloska Cesta 7, 1000, Ljubljana
University Medical Center Ljubljana
#4591: Clinical Department of Vascular Diseases, Zaloska Cesta 7, 1000, Ljubljana
Hospital Unviersitario Miguel Servet
#4207:Servicio Medicina Interna, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
University Hospital Virgen Del Rocio S.L.
#4210:Servicio Medicina Interna, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Reina Sofia
#4208:Servicio Medicina Interna, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Infanta Elena
#4219:Servicio Medicina Interna, Calle Doctor Pedro Naranjo Sn, 21007, Huelva
Bellvitge University Hospital
#4201:Servicio de Cardiología, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Complexo Hospitalario Universitario A Coruna
#4211:Servicio Medicina Interna, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Fundacion Jimenez Diaz
#4205:Servicio de Cardiología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Complexo Hospitalario Universitario De Santiago
#4202:Servicio de Cardiología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Virgen De La Macarena
#4215:Servicio de Cardiología, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Germans Trias I Pujol
#4214:Servicio de Cardiología, Carretera Canyet 1a Planta, 08916, Badalona
Hospital San Pedro De Alcantara
#4220:Servicio de Cardiología, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Salut Sant Joan De Reus
#4204:Servicio Medicina Interna, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Hospital Universitario Virgen De Valme
#4206:Servicio Medicina Interna, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitario 12 De Octubre
#4217:Servicio de Cardiología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Virgen De La Victoria
#4212:Servicio Medicina Interna, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Equip D'atencio Primaria Barcelona Sardenya S.L.P.
#4203:Unidad de Investigación, C Sardenya 466, 08025, Barcelona
Hospital Universitario Marques De Valdecilla
#4209:Servicio de Oncología, Avenida Valdecilla Sn, 39008, Santander
Hospital Clinic De Barcelona
#4216:Servicio de Cardiología, Calle Villarroel 170, 08036, Barcelona
Hospital Clinico Universitario De Valencia
#4213:Servicio de Endocronología y Nutrición, Avenida Blasco Ibanez 17, 46010, Valencia
Kalthus Heart & Horse AB
#4252: Clemenstorgets Hjärtmottagning, S Domkyrkofors., Clemenstorget 5, Lund
Karolinska University Hospital
#4251: Patientforskningscentrum, Halsovagen, Flemingsberg, Huddinge
Sahlgrenska University Hospital-Vastra Gotalandsregionen
#4255: Kardiologens Forskningsenhet, Bla Straket 5, 413 46, Goteborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2020-06-04 | 2020-06-04 | 2022-07-07 | ||
| Belgium | 2020-06-12 | 2020-06-12 | 2022-07-07 | ||
| Bulgaria | 2020-09-01 | 2020-09-01 | 2022-07-07 | ||
| Czechia | 2020-06-11 | 2020-06-11 | 2022-07-07 | ||
| Denmark | 2020-06-12 | 2020-06-12 | 2022-07-07 | ||
| France | 2021-09-17 | 2021-09-17 | 2022-07-07 | ||
| Germany | 2020-03-06 | 2020-03-06 | 2022-07-07 | ||
| Greece | 2021-02-04 | 2021-02-04 | 2022-07-07 | ||
| Hungary | 2020-06-30 | 2020-06-30 | 2022-07-07 | ||
| Iceland | 2020-07-15 | 2020-07-15 | 2022-07-07 | ||
| Italy | 2020-07-28 | 2020-07-28 | 2022-07-07 | ||
| Netherlands | 2020-06-03 | 2020-06-03 | 2022-07-07 | ||
| Norway | 2020-11-02 | 2020-11-02 | 2022-07-07 | ||
| Poland | 2020-10-26 | 2020-10-26 | 2022-07-07 | ||
| Portugal | 2020-08-05 | 2020-08-05 | 2022-07-07 | ||
| Romania | 2021-09-21 | 2021-09-21 | 2022-07-07 | ||
| Slovakia | 2020-06-08 | 2020-06-08 | 2022-07-07 | ||
| Slovenia | 2021-06-23 | 2021-06-23 | 2022-07-07 | ||
| Spain | 2020-09-24 | 2020-09-24 | 2022-07-07 | ||
| Sweden | 2020-10-28 | 2020-10-28 | 2022-07-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 180 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol - Signature Page_1_English_Red | 14May2025 |
| Protocol (for publication) | D1_Protocol_2023-508292-37-00_1_English_Red | 6 |
| Protocol (for publication) | D1_Protocol_2023-508292-37-00_1_Greek_Red | 6 |
| Protocol (for publication) | D4_Patient-facing document - PRO_1_SE_English_Note to Assesor_NonRed | 15Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BE_English_NonRed | 11Feb2020 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BG_English_Note to Assesor_NonRed | 18Jun2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_CZ_NonRed | 05May2022 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DE_English_Note to Assesor_NonRed | 12.06.2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DK_English_NonRed_T | v01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_Spain_NonRed | 13/Jan/20 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_French_NonRed | v01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_GR_English_Note to Assesor_NonRed | 11-Jun-24 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_HU_English_NonRed | v01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IS_English_Note to assessor_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IT_English_NonRed | 01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_NL_English_Note to Assesor_NonRed | V00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PL_English_Note to Assesor_NonRed | 28May2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PT_English_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_RO_English_Note to Assesor_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SE_English_Note to Assesor_NonRed | 01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SI_English_Note to Assesor_NonRed | 28May2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SK_English_Note to Assesor_NonRed | V1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Site_1_AT_English_Note to Assesor_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements-Country_1_NO_English_Note to Assessor_NonRed | 01 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_1_FR_French_Red | V03.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregant participant or pregnant partner of participant_1_FR_French_NonRed | V05.06.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_AT_German_NonRed | v00.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BE_Dutch_NonRed | v0.0a |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BE_English_NonRed | v0.0a |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BE_French_NonRed | v0.0a |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_Bulgarian_NonRed | 3 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_English_NonRed | 00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed | 00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DK_Danish_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | 22Jul2019 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_GR_English_Red | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_GR_Greek_Red | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_HU_Hungarian_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IS_Icelandic_NonRed | 00.00.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed | 06.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_NL_Dutch_NonRed | V00000001 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_NO_Norwegian_NonRed | v00.00.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PL_Polish_NonRed | v03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PT_Portuguese_NonRed | 1.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_RO_Romanian_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SE_Swedish_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SI_Slovenian_NonRed | 00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_2_HU_Hungarian_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_BE_Dutch_NonRed | v04.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_BE_English_NonRed | v04.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_BE_French_NonRed | v04.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_IT_Italian_NonRed | 06.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_AT_German_NonRed | v00.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_BG_Bulgarian_NonRed | 3 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_BG_English_NonRed | 01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_CZ_Czech_Red | v2.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_DK_Danish_NonRed | V2 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_ES_Spanish_NonRed | 03Oct2019 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_GR_English_Red | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_GR_Greek_Red | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_HU_Hungarian_Red | v1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_PL_Polish_NonRed | v03 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_PT_Portuguese_NonRed | 1.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_RO_Romanian_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_SE_Swedish_NonRed | V2 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_SI_Slovenian_NonRed | 01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_2_DK_Danish_NonRed | V3 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_2_HU_Hungarian_NonRed | v1.1 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_1_HU_Hungarian_NonRed | v04.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_1_IT_Italian_NonRed | 04.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_1_PL_Polish_NonRed_T | 02 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_1_SI_Slovenian_NonRed | 04.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_2_HU_Hungarian_NonRed | v04.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_AT_German_Red | 06.07.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_Dutch_Red | 06.07.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_English_Red | 06.07.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_French_Red | 06.07.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_Bulgarian_Red | v06.07.11 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_English_Red | v06.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | 06.07.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DE_German_Red | v05.06.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DK_Danish_Red | v06.07.10 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_Red | v06.07.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_GR_English_Red | v05.06.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_GR_Greek_Red | v06.07.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red | v06.07.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IS_English_NonRed | 24Nov2025 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IS_Icelandic_Red | 06.07.10 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 06.07.09 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NL_Dutch_Red | V05060601 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NO_Norwegian_Red | v06.07.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PL_Polish_Red | v09 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PT_Portuguese_Red | 06.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_RO_Romanian_Red | 06.07.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SE_Swedish_Red | 06.07.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SI_Slovenian_Red | v06.07.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SK_Slovak_Red | 06.07.07.M |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_DE_German_Red | v03.04.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_FR_French_Red | V03.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_German_Red | v06.07.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_HU_Hungarian_NonRed | v04.05.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_SE_Swedish_Red | 04.05.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_3_DE_German_Red | v04.05.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_3_FR_French_NonRed | v05.06.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_4_FR_French_NonRed | v05.06.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_Addendum_1_FR_French_Red | V05.06.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_Addendum_5_FR_French_Red | V06.07.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_CZ_Czech_Red | v3.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_SK_Slovak_NonRed | V2 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional treatment beyond disease progression_1_CZ_Czech_NonRed | V2 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional treatment beyond disease progression_1_ES_Spanish_NonRed | v04.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional treatment beyond disease progression_1_IT_Italian_NonRed | 06.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional treatment beyond disease progression_1_SI_Slovenian_NonRed | 1 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional treatment beyond disease progression_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional treatment beyond disease progression_2_CZ_Czech_NonRed | V2 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_FR_French_NonRed | V05.06.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Pharmacokinetics_1_CZ_Czech_Red | v5.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Pharmacokinetics_1_SK_Slovak_NonRed | V2 |
| Subject information and informed consent form (for publication) | L1_ICF - Pharmacokinetics_2_CZ_Czech_NonRed | V5 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed | V 05.06.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_SK_Slovak_NonRed | V2 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II_2_HU_Hungarian_NonRed | 25Jun2025 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents_1_HU_English_NonRed | 09Jul2024 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_HU_Hungarian_NonRed | v02 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_AT_German_Red | 04 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_FR_French_Red | v1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_IT_Italian_NonRed | 01.00 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_NO_Norwegian_NonRed | 01 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_FR_French_NonRed | 11Oct2022 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_NO_Norwegian_NonRed | 01 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_FR_French_NonRed | v02 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_NO_Norwegian_NonRed | 01 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_4_FR_French_NonRed | v02 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_4_NO_Norwegian_NonRed | 01 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_AT_German_Red | 1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_BG_Bulgarian_NonRed | 1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_CZ_Czech_Red | V1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_DK_English_NonRed_T | v01 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_ES_Spanish_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_GR_English_Red | v1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_IS_English_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_NO_English_NonRed | 01 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_PT_English_NonRed | 1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_SE_Swedish_NonRed | 1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_2_AT_German_Red | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Bulgarian_NonRed | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_French_Red | V5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Hungarian_NonRed | 5.06 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Italian_NonRed | 04.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Polish_NonRed | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Portuguese_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Romanian_NonRed | V5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Slovak_NonRed | V3 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_1_Spanish_NonRed | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_1_Czech_Red | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_BE_Dutch_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Bulgarian_Red | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Czech_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_English_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_French_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_German_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Greek_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Hungarian_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Icelandic_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Italian_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_NL_Dutch_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Norwegian_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Polish_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Portuguese_Red | 02.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Romanian_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Slovak_Red | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Slovenian_Red | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Spanish_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508292-37-00_2_Swedish_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language Translation_2023-508292-37-00_1_Greek_Red | 06 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-508292-37-00_1_Slovenian_Red | v3.0 |
Application history
35 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-26 | Germany | Acceptable 2024-05-03
|
2024-05-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-12 | Germany | Acceptable 2024-10-08
|
2024-10-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-04 | Acceptable 2024-10-08
|
2024-11-04 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-05 | Acceptable 2024-10-08
|
2024-11-05 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-08 | Acceptable 2024-10-08
|
2024-11-08 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-11-11 | Acceptable 2024-10-08
|
2024-11-11 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-11-12 | Acceptable 2024-10-08
|
2024-11-12 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-11-13 | Acceptable 2024-10-08
|
2024-11-13 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2024-11-15 | Acceptable 2024-10-08
|
2024-11-15 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2024-11-18 | Acceptable 2024-10-08
|
2024-11-18 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-29 | Germany | Acceptable 2025-02-06
|
2025-02-06 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-03-03 | Germany | Acceptable 2025-02-06
|
2025-03-03 |
| 13 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-01 | Acceptable | 2025-04-11 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-02 | Acceptable | 2025-04-28 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-04-29 | 2025-04-29 | ||
| 16 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-17 | Germany | Acceptable 2025-10-07
|
2025-10-07 |
| 17 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-30 | Acceptable | 2025-12-02 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-03 | Acceptable | 2025-12-22 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-11-12 | Acceptable | 2025-12-03 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-11-27 | Acceptable | 2026-03-02 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-12-05 | Acceptable | 2025-12-26 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-12-18 | Acceptable | 2026-01-27 | |
| 23 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2026-03-03 | 2026-03-03 | ||
| 24 | NON SUBSTANTIAL MODIFICATION | NSM-12 | 2026-03-03 | 2026-03-03 | ||
| 25 | NON SUBSTANTIAL MODIFICATION | NSM-14 | 2026-03-04 | 2026-03-04 | ||
| 26 | NON SUBSTANTIAL MODIFICATION | NSM-15 | 2026-03-04 | 2026-03-04 | ||
| 27 | NON SUBSTANTIAL MODIFICATION | NSM-16 | 2026-03-04 | 2026-03-04 | ||
| 28 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-03-05 | Acceptable | 2026-03-12 | |
| 29 | NON SUBSTANTIAL MODIFICATION | NSM-17 | 2026-03-24 | Acceptable | 2026-03-24 | |
| 30 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-03-24 | Acceptable | 2026-05-18 | |
| 31 | NON SUBSTANTIAL MODIFICATION | NSM-19 | 2026-05-26 | Acceptable 2025-10-07
|
2026-05-26 | |
| 32 | NON SUBSTANTIAL MODIFICATION | NSM-20 | 2026-05-27 | Acceptable 2025-10-07
|
2026-05-27 | |
| 33 | NON SUBSTANTIAL MODIFICATION | NSM-21 | 2026-05-28 | Acceptable 2025-10-07
|
2026-05-28 | |
| 34 | NON SUBSTANTIAL MODIFICATION | NSM-22 | 2026-05-29 | Acceptable 2025-10-07
|
2026-05-29 | |
| 35 | NON SUBSTANTIAL MODIFICATION | NSM-23 | 2026-06-01 | Acceptable 2025-10-07
|
2026-06-01 |