Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
1
Countries
1
Sites
2
"Patients with interstitial lung disease associated pulmonary hypertension"
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 13 May 2008 → 3 Jul 2025
- Decision date (initial)
- 2024-02-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507526-17-00
- EudraCT number
- 2007-003928-37
- ClinicalTrials.gov
- NCT00694850
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
"Patients with interstitial lung disease associated pulmonary hypertension"
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10037400 | Pulmonary hypertension | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- Kaiser-Wilhelm-Allee 1, Wiesdorf Wiesdorf
- City
- Leverkusen
- Postcode
- 51373
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 1 | 2 |
| 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 |
|---|---|---|---|---|---|
| Germany | 2008-05-13 | 2025-07-03 | 2008-08-02 | 2009-02-16 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-19 | Germany | Acceptable 2024-01-24
|
2024-02-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-11 | Germany | Acceptable | 2024-07-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-05 | Germany | Acceptable | 2024-08-05 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-15 | Germany | Acceptable | 2024-11-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-05 | Germany | Acceptable 2025-04-09
|
2025-04-17 |