Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
20
Countries
1
Sites
7
Cardiology and vascular disease
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Decision date (initial)
- 2025-01-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cardiology and vascular disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10010331 | Congenital familial and genetic disorders | 21 |
| 26.0 | PT | 10056371 | Cerebrovascular arteriovenous malformation | 100000004850 |
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
- Investigateur coordonnateur
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Investigateur coordonnateur
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 20 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Pellegrin Hospital
Neurochirurgie, Place Amelie Raba Leon, 33000, Bordeaux
Hopitaux Universitaires Pitie Salpetriere
Neurochirurgie, 47 To 83 Boulevard De L Hopital, 75013, Paris
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
Neuroradiologie interventionnelle, 1 Rue Cabanis, 75014, Paris
Centre Hospitalier Et Universitaire De Limoges
Neuroradiologie, 2 Avenue Martin Luther King, 87000, Limoges
CHRU De Nancy
Neuroradiologie interventionnelle, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Hopitaux Universitaires Pitie Salpetriere
Neuroradiologie interventionnelle, 47 To 83 Boulevard De L Hopital, 75013, Paris
Pellegrin Hospital
Neuroradiologie interventionnelle, Place Amelie Raba Leon, 33000, Bordeaux
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | France | Acceptable 2025-01-27
|
2025-01-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-18 | France | Acceptable 2025-12-11
|
2025-12-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-31 | France | Acceptable 2025-12-11
|
2026-03-31 |