Ignite Creation Date:
2024-05-05 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00660179
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2008-04-14
Brief Title:
Study of Macitentan ACT-064992 on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multicenter Double-blind Randomized Placebo-controlled Parallel Group Event-driven Phase III Study to Assess the Effects of Macitentan ACT-064992 on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2015-08
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:
SERAPHIN
Brief Summary:
The AC-055-302SERAPHIN study will be an event-driven Phase III study comparing two different doses of macitentan ACT-064992 3 and 10 mg vs placebo in patients with symptomatic PAH The main study objective is to demonstrate that macitentan ACT-064992 prolongs time to the first morbidity or mortality event and to evaluate the benefitrisk profile of macitentan ACT-064992 in the treatment of patients with symptomatic PAH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None