Conditions: Pulmonary Arterial Hypertension
Keywords: PAH-SYMPACT Pulmonary Arterial Hypertension psychometric instrument
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 284
Healthy volunteers: no

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 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.

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: