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SYMPHONY: A Study of Macitentan in Pulmonary Arterial Hypertension to Validate the PAH-SYMPACT

2015-06-10 01:53:23 | BioPortfolio

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 1/2 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pulmonary Arterial Hypertension

Intervention

Macitentan

Location

Cardiovascular Associates of the Southeast, LLC
Birmingham
Alabama
United States
35243

Status

Active, not recruiting

Source

Actelion

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-10T01:53:23-0400

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