Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
200
Countries
1
Sites
29
Pulmonary Hypertension
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] - Respiratory Tract Diseases [C08]
- Trial duration
- 1 Feb 2024 → ongoing
- Decision date (initial)
- 2023-04-20
- 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
Pulmonary Hypertension
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 David MONTANI
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Pr David MONTANI
Locations
1 EU/EEA country · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 200 | 29 |
| Rest of world | — | 0 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Pneumology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Groupe Hospitalier Du Havre
Pneumology, 55 B Rue Gustave Flaubert, Bp 24, Le Havre Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Pneumology, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Centre Hospitalier Universitaire De Caen Normandie
Pneumology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Rennes
Cardiology, 2 Rue Henri Le Guilloux, 35000, Rennes
Bicetre Hospital
Pneumology, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Universitaire De Nice
cardiology, 30 Voie Romaine, 06000, Nice
CHU De Rouen
Pneumology, 1 Rue De Germont, 76031, Rouen Cedex
Institut Des Neurosciences De La Timone
Cardiology, 27 Boulevard Jean Moulin, 13005, Marseille
Centre Hospitalier Universitaire De Saint Etienne
Pneumology, Avenue Albert Raimond, 42270, Saint-Priest-En-Jarez
Centre Hospitalier Regional Universitaire De Tours
Pneumology, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Assistance Publique Hopitaux De Paris
Pneumology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
University Hospital Of Montpellier
Pneumologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Le Mans
Pneumology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire De Nantes
pneumology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Toulouse
Pneumology, Cedex 9, 2 Rue Viguerie, Toulouse
CHU Gabriel-Montpied
Cardiology, 58 Rue Montalembert, 63000, Clermont Ferrand
Centre Hospitalier Universitaire De Bordeaux
Cardiology, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Lille
Cardiology, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Assistance Publique Hopitaux De Marseille
Pneumology, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Regional D'angers
Pneumology, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Regional Universitaire De Nancy
Pneumology, Co N°34, 29 Av Du Mal De Lattre De Tassigny, Nancy Cedex
Centre Hospitalier Universitaire De Reims
Cardiology, 45 Rue Cognacq Jay, 51100, Reims
Assistance Publique Hopitaux De Paris
Pneumology, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Universitaire De Poitiers
Pneumology, 2 Rue De La Miletrie, 86000, Poitiers
Hospices Civils De Lyon
Pneumology, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Limoges University Hospital Dupuytren 1
Pneumology, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Hospitalier Universitaire De Dijon
Pneumology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
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 | 2024-02-01 | 2024-02-01 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-16 | France | Acceptable 2023-04-20
|
2023-04-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-07-12 | France | Acceptable 2023-08-24
|
2023-08-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-10-26 | France | Acceptable 2023-12-11
|
2024-01-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-02-29 | France | Acceptable 2024-04-19
|
2024-06-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-26 | France | Acceptable 2025-01-19
|
2025-02-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-16 | France | Acceptable 2025-12-15
|
2025-12-15 |