Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05818137
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2023-04-05
Brief Title:
A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension PAH Participants MK-7962-020
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Non-randomized Non-controlled Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 Sotatercept add-on to Background Therapy in Japanese Participants With Pulmonary Arterial Hypertension PAH
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This local Phase 3 study is planned to confirm the efficacy and safety in Japanese PAH participants The primary population of this study is Japanese PAH participants with World Health Organization Functional Class WHO FC II or III while the study includes PAH participants with WHO FC I or IV as other populations There are no hypotheses for this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT2031230046 | REGISTRY | None | None |
| MK-7962-020 | OTHER | Merck | None |