Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Arterial Hypertension Ambrisentan Sponsor Rest of World: GSK Tadalafil PAH Sponsor US: Gilead
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 610
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.

Detailed description:

Arms:
arm 1: ambrisentan + tadalafil arm 2: ambrisentan arm 3: tadalafil

Interventions: intervention 1: ambrisentan intervention 2: tadalafil
Intervention descriptions: intervention 1: ambrisentan (target dose: 10mg) intervention 2: tadalafil (target dose: 40mg)

Protocol document: