Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04273945
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2020-01-31
Brief Title:
Outcome Study Assessing a 75 Milligrams mg Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Phase 3 Prospective Multicenter Double-blind Double-dummy Randomized Active-controlled Parallel-group Group-sequential Adaptive Event-driven Study to Compare Efficacy Safety and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension Followed by an Open-label Treatment Period With Macitentan 75 mg
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
UNISUS
Brief Summary:
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams mg in prolonging the time to the first clinical events committee CEC-adjudicated morbidity or mortality MM event in participants with symptomatic pulmonary arterial hypertension PAH compared to macitentan 10 mg
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AC-055-315 | OTHER | Actelion | None |
| 2019-002533-11 | EUDRACT_NUMBER | None | None |