Ignite Creation Date:
2024-05-06 @ 1:35 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01841762
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2013-03-27
Brief Title:
Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
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 PAH-SYMPACT Instrument
Status:
COMPLETED
Status Verified Date:
2019-02
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:
SYMPHONY is prospective multi-center open-label single-arm Phase 3b psychometric validation study of the PAH-SYMPACT a new quality of life questionnaire for patients with pulmonary arterial hypertension Patients will be in the study for 5 12 months 4 months of which they will receive macitentan 10 mg once daily
The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument and to demonstrate the ability of the PAH SYMPACT instrument to detect change The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact as measured by the PAH-SYMPACT in patients with pulmonary arterial hypertension
The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument and to demonstrate the ability of the PAH SYMPACT instrument to detect change The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact as measured by the PAH-SYMPACT in patients with pulmonary arterial hypertension
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