Conditions: Pulmonary Arterial Hypertension
Keywords: PAH-SYMPACT psychometric instrument
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 160
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Macitentan tablet, dose of 10 mg, once daily

Interventions: intervention 1: Macitentan
Intervention descriptions: intervention 1: Macitentan tablet, dose of 10 mg, once daily

Protocol document: