A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain

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.

Timeline

Start

2014-03-01

Primary completion

2015-10-01

Completion

2015-11-01

Drugs

Indications