Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
6,200
Countries
18
Sites
257
Atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
To demonstrate the superiority of ziltivekimab CCI s.c. once-monthly in reducing the risk of MACE (as defined by the primary endpoint) compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation.
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 24 Sep 2021 → ongoing
- Decision date (initial)
- 2024-05-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk A/S
External identifiers
- EU CT number
- 2023-506926-35-00
- EudraCT number
- 2020-004853-59
- WHO UTN
- U1111-1259-3422
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To demonstrate the superiority of ziltivekimab CCI s.c. once-monthly in reducing the risk of MACE (as defined by the primary endpoint) compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation.
Secondary objectives 8
- To demonstrate the superiority of ziltivekimab CCI s.c. once-monthly compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to reducing the risk of expanded MACE (as defined by the confirmatory secondary endpoint)
- To demonstrate the superiority of ziltivekimab CCI s.c. once-monthly compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to reducing the risk of heart failure (as defined by the confirmatory secondary endpoint)
- To demonstrate the superiority of ziltivekimab CCI s.c. once-monthly compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to reducing all-cause mortality
- To demonstrate the superiority of ziltivekimab CCI s.c. once-monthly compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to delaying the progression of CKD (as defined by the confirmatory secondary endpoint)
- To compare the effects of ziltivekimab CCI s.c. once-monthly versus placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to reducing systemic inflammation (defined by the secondary and exploratory endpoints)
- To compare the effects of ziltivekimab CCI s.c. once-monthly versus placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to improving patient reported outcomes (PRO)
- To compare the effects of ziltivekimab CCI s.c. once-monthly versus placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to not increasing severe infections (as defined by secondary safety endpoints)
- To compare the effects of ziltivekimab CCI s.c. once-monthly versus placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation, with regards to improving markers of anaemia (as defined by the supportive secondary endpoint)
Conditions and MedDRA coding
Atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- EMA paediatric investigation plan (PIP)
- EMEA-002840-PIP01-20
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Chronic kidney disease defined by one of the below: eGFR ≥15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation), OR UACR ≥200 mg/g and eGFR ≥60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation).
- Serum hs-CRP ≥2 mg/L
- Evidence of ASCVD by one or more of the following: Coronary heart disease defined as at least one of the following: Documented history of MI, prior coronary revascularisation procedure, or ≥50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography. Cerebrovascular disease defined as at least one of the following: Prior stroke of atherosclerotic origin, prior carotid artery revascularisation procedure, or ≥50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound. Symptomatic peripheral artery disease (PAD) defined as at least one of the following: Intermittent claudication with an ankle-brachial index (ABI) ≤ 0.90 at rest, intermittent claudication with a ≥50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound, prior peripheral artery (excluding carotid) revascularisation procedure, or lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis).
Exclusion criteria 4
- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2).
- Planned coronary, carotid or peripheral artery revascularisation known on the day of randomisation (visit 2).
- Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to first occurrence of 3-point MACE, a composite endpoint consisting of CV death, non-fatal MI, and non-fatal stroke. Measured from randomisation to end-of-study.
Secondary endpoints 20
- Time to first occurrence of expanded MACE, a composite endpoint consisting of CV death, non-fatal MI, non-fatal stroke, and hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation. Measured from randomisation to end-of-study.
- Number of heart failure hospitalisations or urgent heart failure visits or CV deaths from randomisation to end-of-study.
- Time to first occurrence of a composite kidney endpoint consisting of CV death, onset of persistent ≥ 40% reduction in eGFR (CKD-EPI) compared with baseline and kidney failure defined as death from kidney failure, onset of persistent eGFR< 15 mL/min/1.73 m2 (CKD-EPI), or initiation of chronic kidney replacement therapy. Measured from randomisation to end-of-study.
- Time to occurrence of all-cause mortality from randomisation to end-of-study.
- Time to first occurrence of each of the individual components of the expanded MACE endpoint and the kidney composite endpoint from randomisation to end-of-study.
- Time to first occurrence of MIs (fatal and non-fatal) from randomisation to end-of-study.
- Time to first occurrence of stroke (fatal and non-fatal) from randomisation to end-of-study.
- Time to first occurrence of a composite MACE endpoint consisting of all-cause mortality, non-fatal MI, and non-fatal stroke. Measured from randomisation to end-of-study.
- Time to first occurrence of a 4-component kidney endpoint consisting of onset of persistent ≥ 40% reduction in eGFR (CKD-EPI) compared with baseline, and kidney failure defined as death from kidney failure, onset of persistent eGFR< 15 mL/min/1.73 m2 (CKD-EPI), or initiation of chronic kidney replacement therapy. Measured from randomisation to end-of-study.
- Time to first occurrence of coronary revascularisation from randomisation to end-of-study.
- Change in UACR from randomisation to 2 years.
- Change in eGFR (CKD-EPI) from randomisation to 2 years.
- Annual rate of change in eGFR (CKD-EPI) (total eGFR slope) from randomisation to end-of-study.
- Change in hs-CRP from randomisation to 2 years.
- Change in NT-pro-BNP from randomisation to 2 years.
- Change in left ventricular ejection fraction (LVEF) from randomisation to 2 years.
- Number of events of atrial fibrillation from randomisation to end-of-study.
- Change in haemoglobin from randomisation to 2 years.
- Number of hospitalisations with infection as primary cause or death due to infection from randomisation to end-of-study.
- Change in Short Form 36 (SF-36) Physical Component Score (PCS) from randomisation to 2 years.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10000896 · Product
- Active substance
- Ziltivekimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- 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
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU submission Hub
Third parties 17
| Organisation | City, country | Duties |
|---|---|---|
| Caristo Diagnostics Ltd ORL-000006245
|
Oxford, United Kingdom | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| Marken Limited ORG-100050177
|
London, United Kingdom | Other |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| Qualitymetric Incorporated LLC ORG-100044132
|
Johnston, United States | Other |
| Oracle America Inc. ORG-100039874
|
Redwood City, United States | Other |
| International Drug Development Institute ORG-100028563
|
Ottignies-Louvain-La-Neuve, Belgium | Other |
| Affidea Piraeus Biopathological ORG-100047597
|
Pireas, Greece | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Bioiatriki Private Medical Polyclinic S.A. ORG-100047061
|
Athens, Greece | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Other |
| The Brigham And Women’s Hospital Inc. ORG-100030562
|
Boston, United States | Other |
| Oracle Danmark ApS ORG-100044663
|
Hellerup, Denmark | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
Locations
18 EU/EEA countries · 257 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 96 | 9 |
| Bulgaria | Ongoing, recruitment ended | 317 | 19 |
| Croatia | Ongoing, recruitment ended | 47 | 7 |
| Czechia | Ongoing, recruitment ended | 78 | 6 |
| Denmark | Ongoing, recruitment ended | 90 | 7 |
| Germany | Ongoing, recruitment ended | 94 | 25 |
| Greece | Ongoing, recruitment ended | 216 | 22 |
| Hungary | Ongoing, recruitment ended | 105 | 9 |
| Italy | Ongoing, recruitment ended | 110 | 22 |
| Latvia | Ended | 41 | 7 |
| Lithuania | Ongoing, recruitment ended | 55 | 10 |
| Netherlands | Ongoing, recruitment ended | 115 | 11 |
| Poland | Ongoing, recruitment ended | 400 | 32 |
| Portugal | Ongoing, recruitment ended | 106 | 14 |
| Romania | Ongoing, recruitment ended | 170 | 25 |
| Slovakia | Ongoing, recruitment ended | 132 | 14 |
| Spain | Ongoing, recruitment ended | 118 | 11 |
| Sweden | Ended | 45 | 7 |
| Rest of world
Korea, Democratic People's Republic of, Russian Federation, Taiwan, Brazil, Ukraine, United Kingdom, China, Serbia, Thailand, India, Malaysia, Japan, South Africa, Turkey, Australia, Argentina, Canada, Israel, United States, Mexico
|
— | 3,865 | — |
Investigational sites
Centre Hospitalier Regional De La Citadelle
N/A, Bld Du Douzieme-De-Ligne 1, 4000, Liege
Az St-Jan Brugge-Oostende A.V.
N/A, Ruddershove 10, 8000, Brugge
Imelda
N/A, Imeldalaan 9, 2820, Bonheiden
Ziekenhuis Oost Limburg
N/A, Synaps Park 1, 3600, Genk
Algemeen Ziekenhuis Groeninge
N/A, President Kennedylaan 4, 8500, Kortrijk
A.Z. Sint-Maarten
N/A, Liersesteenweg 435, 2800, Mechelen
Algemeen Ziekenhuis Klina
N/A, Augustijnslei 100, 2930, Brasschaat
Algemeen Ziekenhuis Oostende
N/A, Gouwelozestraat 100, 8400, Ostend
Azorg
AZORG Aalst – Moorselbaan - Cardiovasculair Center, Moorselbaan 164, 9300, Aalst
Diagnostic-Consultative Center Alexandrovska EOOD
Clinical Trials Consulting Room, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Medical Center Berbatov Ltd.
N/A, Ulitsa Cherni Drin 15, 8600, Yambol
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Department of Internal diseases, Endocrinology and Metabolic Diseases, Ulitsa Dimitir Pehlivanov 5, 8800, Sliven
Medical Center New Rehabilitation Center EOOD
Endocrinology and Metabolic Diseases Consulting Room, Bulevard Tsar Simeon Veliki 158, 6001, Stara Zagora
Prevencia 2000 MCDMP
Endocrinology and Metabolic Diseases Consulting Room, Bulevard Ruski 56, 6000, Stara Zagora
Medical Center Isul Tsaritsa Yoanna EOOD
N/A, Ulitsa Byalo More 8, 1527, Sofia
Medical Center Medconsult Pleven OOD
N/A, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
University Hospital St. Anna
Department of General Cardiology, Ulitsa Dimitir Mollov 1, 1750, Sofiya
University Hospital St. Anna
Department of Endocrinology and Metabolic Diseases, Ulitsa Dimitir Mollov 1, 1750, Sofiya
Diamedical Medical Center 2013 Ltd.
Endocrinology and Metabolic Diseases Consulting Room, Ulitsa Lyuben Karavelov 22, 6400, Dimitrovgrad
Medical Center Hera EOOD
Еndocrinology and Metabolic Diseases Consulting Room, Ulitsa Klisura 20, 1510, Sofiya
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Clinic of Nephrology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
University Hospital St Marina Varna
II-nd Clinic of Cardiology, Noninvasive diagnostic Department, Hristo Smirnenski St 1, 9010, Varna
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
Clinic of Cardiology, Konstantin Pomyanov Str 1, 1415, Sofia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department of Cardiology, Bulevard Peshtersko Shose 66, 4002, Plovdiv
Мultidisciplinary hospital for active treatment Saint George Pernik OOD
Department of Cardiology, Ulitsa Sveti Kiril I Metodiy 77, 2300, Pernik
Medical Center Medi City OOD
Endocrinology and Metabolic Diseases Consulting room 230, Floor 2, Ulitsa Yavorov 6, Kyustendil
MHAT National Heart Hospital EAD
Clinic of Cardiology, Department of Cardiology, Ulitsa Konyovitsa 65, 1309, Sofiya
Multi-profile Hospital for Active Treatment Heart and Brain EAD
First Department of Cardiology at Clinic of Cardiology, Pierre Curie Street 2, 5804, Pleven
KBC Zagreb
N/A, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
N/A, Ulica Ljudevita Gaja 2, 49217, Krapinske Toplice
Clinical Hospital Centre Rijeka
N/A, Kresimirova 42, 51000, Rijeka
Clinical Hospital Centre Rijeka
N/A, Kresimirova 42, 51000, Rijeka
Clinical Hospital Dubrava
N/A, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
KBC Zagreb
N/A, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Poliklinika Solmed d.o.o.
N/A, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
MEDICON a.s.
N/A, Plynarni 1617/10, Holesovice, Prague
Edumed s.r.o.
N/A, Smetanova 91, 550 01, Broumov
Kardiologie Liberec S.r.o.
N/A, Papirova 525/10, 460 01, Liberec II-Nove Mesto
Nemocnice Slany
N/A, Politickych Veznu 576, 274 01, Slany
Institute For Clinical And Experimental Medicine
N/A, Videnska 1958/9 Krc, 140 00, Prague
Edumed s.r.o.
N/A, Mlynska 189, 547 01, Nachod
Lillebaelt Hospital
N/A, Sygehusvej 24, 6000, Kolding
Region Midtjylland
N/A, Hospitalsparken 15, 7400, Herning
Aalborg University Hospital
N/A, Hobrovej 18/22, 9000, Aalborg
Aarhus Universitetshospital
N/A, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Hvidovre Hospital
N/A, Kettegaard Alle 30, 2650, Hvidovre
Region Sjaelland
N/A, Sygehusvej 10, 4000, Roskilde
Odense University Hospital
N/A, Baagoees Alle 15, 5700, Svendborg
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Universitaetsklinikum Aachen AöR
N/A, Pauwelsstrasse 30, 52074, Aachen
DaVita Clinical Research Deutschland GmbH
N/A, Bismarckstrasse 101, Stadtmitte, Duesseldorf
Praxis Dr.med. Frank Menzel
N/A, Praxis Dr. med. Frank Menzel, Puschkinallee 17, Dessau
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
N/A, Forststrasse 3, Radeberger Vorstadt, Dresden
Charite Universitaetsmedizin Berlin KöR
N/A, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Jena KöR
N/A, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
N/A, Langenbeckstrasse 1, Oberstadt, Mainz
MVZ CCB Frankfurt Und Main-Taunus GbR
N/A, Im Pruefling 23, Bornheim, Frankfurt Am Main
Marienhaus Klinikum Mainz GmbH
N/A, An Der Goldgrube 11, Oberstadt, Mainz
SRH Klinikum Karlsbad-Langensteinbach GmbH
N/A, Guttmannstrasse 1, Langensteinbach, Karlsbad
Praxis Reichelsheim
N/A, Raiffeisenstr. 3, 61203, Reichelsheim
Medical Center - University Of Freiburg
N/A, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
St. Josefskrankenhaus Heidelberg GmbH
N/A, Landhausstrasse 25, Weststadt, Heidelberg
Universitaetsklinikum Schleswig-Holstein AöR
N/A, Ratzeburger Allee 160, 23538, Luebeck
ClinPhenomics CVC GmbH
N/A, Schaumainkai 101-103, Sachsenhausen, Frankfurt Am Main
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Zentrum für klinische Forschung, Dr. med. Lüdemann
N/A, Zentrum für Klinische Studien, Poststraße 46 und 48-50, Falkensee
Universitaet Des Saarlandes
N/A, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum des Saarlandes AöR
N/A, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Halle (Saale) AöR
N/A, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Herzzentrum Dresden GmbH Universitaetsklinik
N/A, Fetscherstrasse 76, Johannstadt-Nord, Dresden
Universitaetsklinikum Frankfurt AöR
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
SANA Kliniken Oberfranken Coburg GmbH
N/A, Ketschendorfer Strasse 33, 96450, Coburg
Zentrum für klinische Studien Südbrandenburg GmbH
N/A, Zentrum für klinische Studien Südbrandenburg GmbH, Lange Straße 13, Elsterwerda
Athens Medical Center S.A.
European Interbalkan Medical Center, Department of internal medicine, Pylea, Asklipiou 10, Thessaloniki
Hippokration Hospital
A’ University Cardiology Clinic, Vassilissas Sofias Avenue 114, 115 27, Athens
General Hospital Of Nea Ionia Konstantopouleio Patision
Cardiology Clinic, Konstadopoulou Th. 3-5, 142 33, Nea Ionia
General University Hospital Of Larissa
Internal Medicine Clinic, P. O. Box 1425, 411 10, Larissa
Thoracic General Hospital Of Athens I Sotiria
3rd University Cardiology Clinic, Messogion Avenue 152, 115 27, Athens
Athens Medical Center S.A.
Heart Failure Clinic, Distomou 5-7, 151 25, Maroussi
Athens Medical Center S.A.
Diabetes Department, Areos 36, 175 62, Paleo Faliro
Thermi Clinic S.A.
Internal Medicine Clinic, 14th Kms N Moudanion, 570 01, Thessaloniki
Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.
6th Cardiology Clinic, Erithrou Stavrou 4, 151 24, Maroussi
University General Hospital Of Thessaloniki Ahepa
A’ Cardiology Clinic, 1st St Kiriakidis Str, 546 36, Thessaloniki
University General Hospital Of Ioannina
Internal Medicine Department, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Of Heraklion
Department of Internal Medicine, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Of Alexandroupoli
University Cardiology Clinic, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
General Hospital Of Thessaloniki Agios Pavlos
Nephrology Unit, Ethnikis Adistasseos 161, 551 34, Kalamaria
Alexandra Hospital
Department of Clinical Therapeutics (NKUA), Vassilissas Sofias Avenue 80, 115 28, Athens
Laiko General Hospital Of Athens
1st department of Propaedeutic Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
Hippokration Hospital
2nd Prop. Dpt. Internal Medicine, Konstadinoupoleos 49, 546 42, Thessaloniki
General Hospital Of Chios Skylitseio
Cardiology Clinic, Elenas Venizelou 2, 821 31, Chios
Geniko Nosokomeio Thessalonikis George Papanikolaou
Cardiology Department, Exochi, 570 10, Thessaloniki
Hippokration Hospital
Department of Nephrology, Konstadinoupoleos 49, 546 42, Thessaloniki
University General Hospital Attikon
2nd Department of Internal Medicine – Research Unit and Diabetes Centre, Rimini Street 1, 124 62, Athens
General University Hospital Of Patras
Department of Nephrology and Renal Transplantation, Rio, 265 04, Patras
Komaromi Selye Janos Korhaz
Cardiology Clinic, Szechenyi Utca 2, Szony, Komarom
Eureka-Center Bt.
N/A, Fulep Lajos Utca 18, 6500, Baja
Belvarosi Egeszseghaz Kft.
Leda Platan Maganklinika, Platan Sor 2-4, 8900, Zalaegerszeg
Gottsegen National Cardiovascular Center
Department of Adult Cardiology, Kerulet, Haller Utca 29/IX., Budapest
Pericardio Kft.
Dr. Lakatos Ferenc Kardiologus ,Belgyogyasz Magan szakrendeles, Also Koros Sor 21, 5600, Bekescsaba
Cardiomobile Kft.
Tagore Medical Center, Gyogy Ter 3, 8230, Balatonfured
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet
1st Department of Internal Medicine and Cardiology, Koves Ut 1, 1204, Budapest
University Of Szeged
1st Department of Internal Medicine, Tisza Lajos Korut 109, 6725, Szeged
University Of Debrecen
Department of Cardiology and Cardiac Surgery, Moricz Zsigmond Korut 22, 4032, Debrecen
Azienda Unita Locale Socio Sanitaria N 8 Berica
N/A, Via Del Parco 1, 36071, Arzignano
Fondazione IRCCS Policlinico San Matteo
N/A, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero Universitaria Pisana
N/A, Via Paradisa 2, 56124, Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NA, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
N/A, Via Del Vespro 129, 90127, Palermo
Ospedale San Raffaele S.r.l.
N/A, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero-Universitaria Sant Andre
N/A, Via Di Grottarossa 1035-1039, 00189, Rome
Universita' Degli Studi Di Ferrara
N/A, Via Aldo Moro 8, 44124, Ferrara
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
N/A, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Policlinico Universitario Tor Vergata
N/A, Viale Oxford 81, 00133, Rome
ARNAS Civico Di Cristina Benfratelli
N/A, Piazza Nicola Leotta 4, 90127, Palermo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
N/A, Via Pietro Albertoni 15, 40138, Bologna
Universita' Degli Studi G. D'annunzio Di Chieti
N/A, Via Luigi Polacchi 11, 66100, Chieti Scalo
Azienda Ospedaliera Universitaria Federico II Di Napoli
N/A, Via Sergio Pansini 5, 80131, Naples
Azienda Sanitaria Universitaria Giuliano Isontina
N/A, Via Costantino Costantinides 2, 34128, Trieste
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
ASST degli Spedali Civili di BresPresidio Ospedaliero di Montichiari, Via Giuseppe Ciotti N. 154, 25018, Montichiari
Careggi University Hospital
N/A, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Per L'Emergenza Cannizzaro
N/A, Via Messina 829, 95126, Catania
Azienda Ospedaliero Universitaria Renato Dulbecco
NA, Viale Europa, 88100, Catanzaro
Azienda Ospedaliera Universitaria Integrata Verona
N/A, Piazzale Aristide Stefani 1, 37126, Verona
Centro Cardiologico Monzino S.p.A.
N/A, Via Carlo Parea 4, 20138, Milan
IRCCS Ospedale Policlinico San Martino
N/A, Viale Benedetto XV 6, 16132, Genoa
Zemgales diabeta centrs SIA
N/A, Zemgales Prospekts 15, LV-3001, Jelgava
Pauls Stradins Clinical University Hospital
N/A, Pilsonu Iela 13, 1002, Riga
Daugavpils Regional Hospital SIA
N/A, Vasarnicu Iela 20, 5417, Daugavpils
Adoria SIA
N/A, Aleksandra Caka Street 70-3, 1011, Riga
Rigas Austrumu kliniska universitates slimnica SIA
N/A, Hipokrata Iela 2, LV-1079, Riga
Pauls Stradins Clinical University Hospital
N/A, Pilsonu Iela 13, 1002, Riga
Ari Med Ltd.
N/A, Vienibas street 4, LV5401, Daugavpils
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
N/A, Eiveniu G. 2, Kauno M. Sav., Kaunas
Kaunas city polyclinic Public institution
N/A, Pramones Pr. 31, Kauno M. Sav., Kovno
Klaipedos universiteto ligonine VšĮ
N/A, Liepojos G. 45, Klaipedos M. Sav., Klaipeda
Klinikiniai Sprendimai UAB
N/A, P. Luksio G. 3, Kauno M. Sav., Kovno
Inlita UAB
N/A, Santariskiu G. 5, Vilniaus M. Sav., Vilnius
Klinikiniai Sprendimai UAB
N/A, Vilties G. 4-46, Alytaus M. Sav., Alytus
Kaunas city polyclinic Public institution
N/A, Pramones Pr. 31, Kauno M. Sav., Kovno
Pirmoji Viltis UAB
N/A, P. Luksio G. 8, Siauliu M. Sav., Siauliai
Saules seimos medicinos centras UAB
N/A, Partizanu G. 27d, Kauno M. Sav., Kaunas
Panevezys Republican Hospital VšĮ
N/A, Smelynes G. 25, Panevezio M. Sav., Panevezys
Gelre Hospitals
N/A, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Academisch Medisch Centrum
N/A, Meibergdreef 9, 1105 AZ, Amsterdam
Ziekenhuisgroep Twente Stichting
N/A, Zilvermeeuw 1, 7609 PP, Almelo
Tergooiziekenhuizen
N/A, Laan Van Tergooi 2, 1212 VG, Hilversum
Ziekenhuis St Jansdal
N/A, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Bravis Ziekenhuis
N/A, Boerhaavelaan 25, 4708 AE, Roosendaal
D & A Research B.V.
N/A, Hegedyk 9, 8601 ZR, Sneek
Amphia Hospital
N/A, Molengracht 21, 4818 CK, Breda
Noordwest Ziekenhuisgroep Stichting
N/A, Wilhelminalaan 12, 1815 JD, Alkmaar
Zaans Medisch Centrum Stichting
N/A, Koningin Julianaplein 58, 1502 DV, Zaandam
Ikazia Ziekenhuis
N/A, Montessoriweg 1, 3083 AN, Rotterdam
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
N/A, Ul. Przedzalniana 66, 90-338, Lodz
Praktyka Lekarska Mateusz Sidor
NA, ul. Rusznikarska 17, 31-261, Kraków
Aka-Med Centrum Sp. z o.o. S.K.
N/A, Ul. 1 Maja 323, 41-710, Ruda Slaska
Pro Life Medica Sp. z o.o.
N/A, Ul. Fabryczna 18, 24-320, Poniatowa
Uniwersytecki Szpital Kliniczny W Poznaniu
N/A, Ul. Dluga 1/2, 61-848, Poznan
Szpital Powiatowy im. Hrabiego Stanisława Lubieńskiego Samodzielny P. Zakład Opieki Zdrowotne
N/A, Ul. Tadeusza Kościuszki 201, 07-100, Węgrów
Velocity Nova Sp. z o.o.
NA, Ul. Peowiakow 1, 22-400, Zamosc
Velocity Nova Sp. z o.o.
NA, Ul. Waclawa Sieroszewskiego 34, 24-100, Pulawy
Kresmed Sp. z o. o.
Trial Medica, Ul. Waska 15a, 15-481, Bialystok
Uniwersytecki Szpital Kliniczny W Bialymstoku
N/A, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Specjalistyczna Praktyka Lekarska w Ogrodzieńcu
N/A, Plac Wolności 23, 42-440, Ogrodzieniec
American Heart Of Poland S.A.
N/A, Ul. Topolowa 16, 32-500, Chrzanow
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
N/A, Ul. Studzienna 35-36/a, 82-300, Elblag
Kardio Life
NA, Warszawska 15/17, 87-800, Włocławek
NBR Polska Tomasz Klodawski
N/A, Aleja Wincentego Witosa 31, 00-710, Warsaw
Specjalistyczna Praktyka Lekarska L. Bryniarski
N/A, Kaziemierza Wielkiego 118, 30-082, Krakow
Salve Medica Sp. z o.o. S.K.
N/A, Ul. Szparagowa 10, 91-211, Lodz
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
N/A, Ul. Rudolfa Weigla 5, 53-114, Wroclaw
ZDROWIE S.C. AGNIESZKA I DONALD DROŻDŻ Kliniki Medyczne Zdrowie Wroclaw
N/A, Gorlicka 62/1U, 51-134, Wroclaw
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
N/A, Alpejska 42, 04-628, Warsaw
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
N/A, Ul. Pradnicka 80, 31-202, Cracow
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
N/A, Alpejska 42, 04-628, Warsaw
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
N/A, Szarych Szeregow 38/III/1, 66-400, Gorzow Wielkopolski
Indywidualna Specjalistyczna Praktyka Lekarska W Dziedzinie Kardiologii Lek Med. Krzysztof Cymerman
N/A, Ul. Mjr. Henryka Sucharskiego 2, 81-157, Gdynia
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
N/A, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
Centermed Sp. z o.o.
N/A, Ul. Weteranow 46, 20-044, Lublin
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
N/A, Ul. Rusznikarska 17, 31-261, Cracow
Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II
N/A, Ul. Daleka 11, 05-825, Grodzisk Mazowiecki
Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego W Lodzi Centralny Szpital Weteranow SPZOZ
Centralny Szpital Weteranow, Ul. Stefana Zeromskiego 113, 90-549, Lodz
Institute Of Polish Mother's Health Center
N/A, Ul. Rzgowska 281/289, 93-338, Lodz
CENTRUM MEDYCZNE VITA Praktyka Kardiologiczna
N/A, Bohaterow Warszawy 101/1, 70-341, Szczecin
American Heart Of Poland S.A.
N/A, Ul. Edukacji 102, 43-100, Tychy
Unidade Local de Saude de Sao Joao E.P.E.
N/A, Alameda Professor Hernani Monteiro, 4200-319, Porto
Unidade Local De Saude De Gaia/Espinho E.P.E.
N/A, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Santa Maria E.P.E.
N/A, Avenida Professor Egas Moniz, 1649-035, Lisbon
Centro Hospitalar Do Tamega E Sousa E.P.E.
N/A, Avenida Do Hospital Padre Americo 210, 4560-136, Guilhufe
Unidade Local De Saude Da Arrabida E.P.E.
N/A, Rua Camilo Castelo Branco, 2910-446, Setubal
Unidade Local De Saude De Lisboa Ocidental E.P.E.
N/A, Av Prof Dr Reinaldo Dos Santos, 2790-134, Carnaxide
APDP Associacao Protectora Dos Diabeticos De Portugal
N/A, Rua Rodrigo Da Fonseca 1, 1250-189, Lisbon
Unidade Local De Saude De Matosinhos E.P.E.
N/A, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Unidade Local De Saude De Coimbra E.P.E.
N/A, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude Do Alto Minho E.P.E.
N/A, Estrada De Santa Luzia, 4904-858, Viana Do Castelo
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
N/A, Avenida De Artur Ravara, 3814-501, Aveiro
Unidade Local De Saude De Almada-Seixal E.P.E.
N/A, Avenida Torrado Da Silva, 2805-267, Almada
CCAB Centro Clinico Academico Braga Associacao
N/A, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Lisboa Ocidental E.P.E.
N/A, Estrada Forte Do Alto Duque, 1449-005, Lisbon
Neurocord Medical S.R.L
Cardiologie, Strada Macedonski Alexandru No 37, 200383, Craiova
Institutul De Boli Cardiovasculare Timisoara
Cardiologie, Strada Adam Gheorghe Nr 13a, 300310, Timisoara
Bella Praxis S.R.L.
Cardiologie, Aleea Tineretului Nr 4, 705200, Pascani
Institutul de Boli Cardiovasculare "Prof. Dr.. George I.M. Georgescu" Iasi
Cardiologie, Bdul Carol l nr. 50, jud. Iasi, Iasi
Cardio Med S.R.L.
Cardiologie, Strada Spania Nr 35a, 200513, Craiova
Davius Clinicmed S.R.L.
Cardiologie, Str Locotenent Maior Laurentiu Claudian Nr 53, 021875, Bucharest
Spitalul Clinic Judetean De Urgenta Bihor
Nefrologie, Calea Coposu Corneliu Nr 12, 410469, Oradea
Lotus Med S.R.L.
Cardiologie, Strada Dornei 79-81, 012292, Bucharest
CMI Dr. Podoleanu Cristian
Cardiologie, Aleea Cornisa, Nr. 5, Targu-Mures
Consultmed S.R.L.
Cardiologie, Block 550, Soseaua Pacurari 70, Jassi
Elias University Emergency Hospital
Cardiologie, Bulevardul Marasti 17, 011461, Bucharest
Sal Med S.R.L.
Cardiologie, Block P7 Scara E Etaj P, Strada Traian, Pitesti
Donna Medplus S.R.L.
Cardiologie, Strada Ing. George Constantinescu 2-4, 020339, Bucharest
Spitalul Clinic Municipal De Urgenta Timisoara
Cardiologie, Strada Dima Gheorghe Nr.5, 300079, Timisoara
Cabinet Medical Individual de Cardiologie Dr. Pop Calin
Cardiologie, Strada George Cosbuc Nr 25A, ap2, Baia Mare
Spitalul Judetean De Urgenta Braila
Cardiologie, Soseaua Buzaului 2, 810325, Braila
Hightech Medical Services S.R.L.
Cardiologie, Sector 1 Alexandra Ioan Cuza Blvd 76, 011053, Bucharest
Spitalul Universitar De Urgenta Bucuresti
Cardiologie, Splaiul Independentei 169, 050098, Bucharest
Centrul Medical Emerald Bucuresti
Cardiologie, Street Nicolae Caramfil Nr 75, 014146, Bucharest
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Cardiologie, Bulevardul Tomis Nr 145, 900591, Constanta
Spitalul Clinic Judetean De Urgenta Targu Mures
Cardiologie, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Diamed Obesity S.R.L.
Diabet, Gheorghe Doja Nr 73, 800291, Galati
Spitalul Clinic De Urgenta Sf.Ioan
Cardiologie, Soseaua Vitan-Barzesti Nr 13, 042122, Bucharest
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Cardiologie, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Mat Cord Biomedica S.R.L.
Cardiologie, Strada Titulescu Nicolae 11, 120133, Buzau
CINRE s.r.o.
Kardiologicka ambulancia, Tematinska 5a, 851 05, Petrzalka
InterStom s.r.o.
Ambulancia vnutorneho lekarstva, Cajkovskeho 2, Klokocina, Nitra
Diabeda s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Tbiliska 6, Raca, Bratislava
University Hospital Bratislava
I. Interna klinika LF UK a UNB, Mickiewiczova 13, Stare Mesto, Bratislava
Kardiomed Nz s.r.o.
Kardiologicka ambulancia, L. Stura 18, 940 02, Nove Zamky
Medical KG s.r.o.
Ambulancia vnutorneho lekarstva, Radlinskeho 51, 921 01, Piestany
Medical group Kosice s.r.o.
Kardiologicka ambulancia, Mudronova 29, Juh, Kosice
Kardio 1 s.r.o.
Kardiologicka ambulancia, Pavla Dobsinskeho 13, 984 03, Lucenec
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Kardiologicka ambulancia, Jana Holleho 5898/14, 080 01, Presov
Cardioconsult s.r.o.
Kardiologicka ambulancia, Cajkovskeho 5, 811 04, Stare Mesto
Narodny Endokrinologicky A Diabetologicky Ustav
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Kollarova 282/3, 034 91, Lubochna
Vital s.r.o.
Ambulancia vnutorneho lekarstva, Hurbanova 3, 934 01, Levice
Národny ustav srdcovych a cievnych chorob a.s.
Klinika kardiologie a angiologie LF SZU, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
Imcore s.r.o.
Kardiologicka ambulancia, Slovenska 86, 080 01, Presov
University Clinical Hospital Virgen De La Arrixaca
N/A, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Nisa Sevilla Aljarafe
N/A, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitario Dr Peset Aleixandre
N/A, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital General Universitario Reina Sofia
N/A, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Virgen Del Camino
N/A, Carretera De Chipiona Sn, 11540, Sanlucar De Barrameda
Hospital Virgen De Las Montanas
N/A, Paseo Ambulatorio Sn, 11650, Villamartin
Hospital Universitario Puerta De Hierro De Majadahonda
N/A, Calle De Manuel De Falla 1, 28222, Majadahonda
Bellvitge University Hospital
N/A, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Unviersitario Miguel Servet
N/A, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Clinico Universitario De Valencia
N/A, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario De Cruces
N/A, Cruces Plaza S/n, 48903, Barakaldo
Karolinska University Hospital
Huddinge Tema Hjärta Kärl, Halsovagen, Flemingsberg, Huddinge
Region Skane Skanes Universitetssjukhus
Forskningsmottagning Internmedicin, Ruth Lundskogs Gata 3, Malmo St Johannes, Malmo
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Njurmedicin, Njurmottagningen, Bla Straket 5, 413 46, Goteborg
Region Oerebro Laen
Njursektionen Medicinkliniken, Sodra Grev Rosengatan, 701 85, Orebro
Karolinska University Hospital
FOU Tema Hjärta Kärl, Norrbacka S3 02, 171 76, Stockholm
Uppsala University Hospital
Forskning Njurmedicin, Dag Hammarskjolds Vag 20, Uppsala Domkyrkofors., Uppsala
Kalthus Heart & Horse AB
Clemenstorgets Hjärtmottagning, S Domkyrkofors., Clemenstorget 5, Lund
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 |
|---|---|---|---|---|---|
| Belgium | 2021-10-29 | 2021-11-04 | 2024-04-09 | ||
| Bulgaria | 2021-11-16 | 2021-11-16 | 2024-04-04 | ||
| Croatia | 2023-02-09 | 2023-02-27 | 2024-03-28 | ||
| Czechia | 2022-10-21 | 2022-11-09 | 2024-03-18 | ||
| Denmark | 2021-12-09 | 2021-12-22 | 2024-05-07 | ||
| Germany | 2021-11-25 | 2021-12-01 | 2024-03-27 | ||
| Greece | 2021-10-25 | 2021-11-04 | 2024-03-27 | ||
| Hungary | 2022-10-03 | 2022-11-22 | 2024-04-02 | ||
| Italy | 2021-11-09 | 2021-11-10 | 2024-04-03 | ||
| Latvia | 2022-10-14 | 2026-05-26 | 2022-10-26 | 2024-04-08 | |
| Lithuania | 2021-09-24 | 2021-09-28 | 2024-04-09 | ||
| Netherlands | 2021-10-08 | 2021-11-05 | 2024-04-03 | ||
| Poland | 2021-10-04 | 2021-10-13 | 2024-04-09 | ||
| Portugal | 2022-02-21 | 2022-02-25 | 2024-02-21 | ||
| Romania | 2022-12-30 | 2023-01-18 | 2024-04-09 | ||
| Slovakia | 2021-09-24 | 2021-09-27 | 2024-04-05 | ||
| Spain | 2022-02-10 | 2022-02-22 | 2024-04-09 | ||
| Sweden | 2021-12-17 | 2026-05-20 | 2022-03-22 | 2024-04-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-109970
- Sponsor became aware
- 2025-12-01
- Date of breach
- 2025-07-07
- Submission date
- 2025-12-08
- Member states concerned
- Belgium, Bulgaria, Croatia, Czechia, Denmark, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Portugal, Romania, Spain, Sweden, Netherlands, Poland, Slovakia
- Categories
- Protocol
- Areas impacted
- Subject rights, Subject safety, Data reliability or robustness
- Benefit-risk balance changed
- No
- Description
- A relocation of the site facility proceeded without final executed transfer agreement, resulting in trial materials, participants’ source binder and Investigator Trial Master File (ITMF) remained at the initial site facility interrupting trial participants’ visits, trial product dispensation and proper documentation.
The member state most affected is Germany. - Sponsor actions
- All trial materials were reestablished at the new site on 24-Oct-2025, and a new trial product shipment was delivered on 26-Nov-2025. The CRA trained the new study nurses during the monitoring visit on 25-Nov-2025 and confirmed site staff system access was activated. The PI will schedule an onsite participant visit before the end of 2025, with another monitoring visit
planned for January 2026. The PI and staff will reconstruct missing visit documentation using available records and record any data gaps in a formal evidence log.
| Organisation | City | Country | Type |
|---|---|---|---|
| SANA Kliniken Oberfranken Coburg GmbH | Coburg | Germany | Clinical investigator |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 191 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_EX6018-4758_Protocol EU CT 2023-506926-35_ENG_For publication | 14 |
| Protocol (for publication) | D1_EX6018-4758_Protocol EU CT 2023-506926-35_Greek_For publication | 14 |
| Protocol (for publication) | Patient facing material with copyright_blank document | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Recruitment arrangements (for publication) | K_EX6018-4758 Transition document_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Future Research Biomarkers FR_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC future research echocardio DU_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Future Research echocardio FR_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Future-research-biomarkers DU_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Main DU_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Main FR_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Male Partner DU_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Male Partner FR_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Optional pre-screening DU_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_BE EX6018-4758 SI-IC Optional pre-screening FR_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_BG EX6018-4758 SI-IC Direct Shipment_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BG EX6018-4758 SI-IC Future research biomarkers_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BG EX6018-4758 SI-IC Future research echo_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BG EX6018-4758 SI-IC Main_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_BG EX6018-4758 SI-IC Male partner_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BG EX6018-4758 SI-IC Optional Pre-screening_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_BG_EX6018-4758 SI-IC Future research biomarkers_English_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_BG_EX6018-4758 SI-IC Main_English_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC biomarkers_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC Direct to patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC ECHO_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC Home care_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC Main for enrolled subjects_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC Main_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC Male partner_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC Pre-screening_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC Subject GDPR enrolled subjects_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_CZ EX6018-4758 SI-IC Subject GDPR_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_CZ_EX6018-4758 SI-IC Biomarker substudy for enrolled subjects_czech_for publication | 3 |
| Subject information and informed consent form (for publication) | L1_DE EX6018-4758 SI-IC Direct to patient_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_DE EX6018-4758 SI-IC Future Research Biomarker_For publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_DE EX6018-4758 SI-IC Future Research Echo_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_DE EX6018-4758 SI-IC Main_For publication | 6.0 |
| Subject information and informed consent form (for publication) | L1_DE EX6018-4758 SI-IC Male partner_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_DE EX6018-4758 SI-IC Optional Pre-Screening_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_DE EX6018-4758 SI-IC Patient app_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_DK EX6018-4758 SI-IC CT sub-study_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_DK EX6018-4758 SI-IC Main_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_DK EX6018-4758 SI-IC Pre-screening_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_DK_EX6018-4758 SI-IC Main_Danish_Dine rettigheder som forsgsperson_For publi | 1 |
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Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-22 | Denmark | Acceptable 2024-04-30
|
2024-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-10 | Denmark | Acceptable 2024-10-11
|
2024-10-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-13 | Acceptable | 2025-02-14 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-15 | Acceptable | 2025-02-18 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-22 | Acceptable | 2025-01-21 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-03 | Acceptable | 2024-12-17 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-06 | Acceptable | 2024-12-13 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-03-04 | Denmark | Acceptable 2025-05-02
|
2025-05-02 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-18 | Denmark | Acceptable 2025-05-02
|
2025-06-18 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-30 | Denmark | Acceptable 2025-08-29
|
2025-08-29 |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-10-07 | Acceptable | 2025-11-07 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-09 | Acceptable | 2025-11-10 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-10-10 | Acceptable | 2025-10-28 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-12-05 | Denmark | Acceptable | 2026-02-02 |
| 15 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-03-11 | Acceptable | 2026-03-31 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-03-31 | Acceptable | 2026-05-26 |