Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
12
Countries
1
Sites
1
Non-ischemic Dilated Cardiomyopathies
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 31 May 2023 → ongoing
- Decision date (initial)
- 2024-11-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512231-72-00
- EudraCT number
- 2022-001844-75
- ClinicalTrials.gov
- NCT05774509
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-ischemic Dilated Cardiomyopathies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10007541 | Cardiac disorders | 11 |
| 26.0 | LLT | 10059868 | Non-ischemic dilated cardiomyopathy | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Pr Philippe MENASCHÉ
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Touria EL AAMRI
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| France | 2023-05-31 | 2023-05-31 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | France | Acceptable 2024-11-08
|
2024-11-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-24 | France | Acceptable 2024-11-08
|
2025-04-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-28 | France | Acceptable 2025-12-10
|
2025-12-17 |