Ignite Creation Date:
2024-05-06 @ 1:35 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01847014
Status:
TERMINATED
Last Update Posted:
2018-08-22
First Post:
2013-05-02
Brief Title:
Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
AC-055-402 An Extension of AC-055-401 a Multi-center Open-label Single-arm Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol-defined criterion of macitentan availability achieved
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYMPHONYext
Brief Summary:
SYMPHONY Extension is an extension of AC-055-401 a multi-center open-label single-arm Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study
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