Ignite Creation Date:
2024-05-06 @ 2:44 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02112487
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2014-04-08
Brief Title:
Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
An Extension of AC-055-310 a Multi-center Open-label Single-arm Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French Italian and Spanish Versions of the PAH-SYMPACT
Status:
COMPLETED
Status Verified Date:
2019-09
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:
Prospective multi-center open-label single-arm Phase 3b extension study of macitentan in patients with PAH
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension PAH beyond treatment in the AC-055-310 study
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension PAH beyond treatment in the AC-055-310 study
Detailed Description:
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension PAH beyond treatment in the AC-055-310 study
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