Ignite Creation Date:
2024-05-06 @ 2:36 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02081690
Status:
TERMINATED
Last Update Posted:
2018-03-21
First Post:
2014-03-05
Brief Title:
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT in France Italy and Spain
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
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:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORCHESTRA
Brief Summary:
Prospective multi-center open-label single-arm Phase 3b psychometric validation study
Primary objectives To evaluate the psychometric characteristics of reliability and construct validity of the French Italian and Spanish versions of the PAH-SYMPACT
To evaluate the ability of the French Italian and Spanish versions of the PAH SYMPACT to detect change
Secondary objective To assess the safety of macitentan in patients with pulmonary arterial hypertension PAH
Exploratory objective To explore the effects of macitentan on PAH symptoms and their impact as measured by the PAH-SYMPACT in patients with PAH in France Italy and Spain
Primary objectives To evaluate the psychometric characteristics of reliability and construct validity of the French Italian and Spanish versions of the PAH-SYMPACT
To evaluate the ability of the French Italian and Spanish versions of the PAH SYMPACT to detect change
Secondary objective To assess the safety of macitentan in patients with pulmonary arterial hypertension PAH
Exploratory objective To explore the effects of macitentan on PAH symptoms and their impact as measured by the PAH-SYMPACT in patients with PAH in France Italy and Spain
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