Conditions: Idiopathic Pulmonary Fibrosis Pulmonary Hypertension
Keywords: Idiopathic Pulmonary Fibrosis Pulmonary Hypertension PH IPF Ambrisentan ERA Endothelin Receptor Antagonist Cardiovascular
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.

Detailed description:

Arms:
arm 1: Participants were randomized to receive ambrisentan treatment at an initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 52 weeks arm 2: Participants were randomized to receive placebo to match ambrisentan for 48 weeks, then transition to ambrisentan treatment at the initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 4 weeks.

Interventions: intervention 1: Ambrisentan intervention 2: Placebo
Intervention descriptions: intervention 1: Ambrisentan (5 mg or 10 mg tablet) administered orally once daily. intervention 2: Placebo to match ambrisentan administered orally once daily.

Protocol document: