Conditions: Pulmonary Arterial Hypertension
Keywords: exercise capacity Eisenmenger Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 226
Healthy volunteers: no

Brief summary:
Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

Detailed description:

Arms:
arm 1: Subjects receive macitentan 10 mg oral tablet once daily arm 2: Subjects receive macitentan-matching placebo oral tablet once daily

Interventions: intervention 1: Macitentan 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Macitentan 10 mg oral tablet once daily intervention 2: Macitentan-matching placebo oral tablet once daily

Protocol document: