A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
Status:
Terminated
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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.