Conditions: Hypertension
Keywords: Endothelin Receptor Antagonist Inoperable Chronic Thromboembolic Pulmonary Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: no

Brief summary:
It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel group, 16 week study will compare the safety and efficacy of ambrisentan 5 milligrams (mg) versus placebo in subjects with inoperable CTEPH. The study will enrol 160 subjects, to assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out rate.

Detailed description:

Arms:
arm 1: Subjects in this arm will receive ambrisentan 5 mg tablet once daily during the treatment period. arm 2: Subjects in this arm will receive ambrisentan-matching placebo tablet once daily during the treatment period.

Interventions: intervention 1: Ambrisentan 5 mg intervention 2: Placebo
Intervention descriptions: intervention 1: White, film-coated, immediate-release tablets, containing 5 mg ambrisentan for single dose oral. intervention 2: White, film-coated, ambrisentan-matching placebo tablet for single oral dose

Protocol document: