Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
1
Pulmonary Arterial Hypertension
Key facts
- Sponsor
- Actelion Pharmaceuticals Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- completed 22 Mar 2024
- Decision date (initial)
- 2024-02-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pulmonary Arterial Hypertension
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Actelion Pharmaceuticals Ltd.
- Sponsor organisation
- Actelion Pharmaceuticals Ltd.
- Address
- Gewerbestrasse 16
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Actelion Pharmaceuticals Ltd.
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Actelion Pharmaceuticals Ltd.
- Contact name
- CTIS Point of Contact
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
CHU De Rouen
Service de pharmacologie clinique, 1 Rue De Germont, Bp 96031, Rouen Cedex
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-28 | France | Acceptable 2024-01-29
|
2024-02-05 |