Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension (PAH) psychometric instrument PAH-SYMPACT
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.

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: