A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.
Subjects in these randomized studies will receive one of two doses of ambrisentan or placebo. Inclusion is not based on a specified WHO functional classification. Rather, subjects with WHO Class I-IV symptoms are eligible if their 6-minute walk distance is 150-450 meters and they meet the study-specified hemodynamic criteria. Subjects with anorexigen or HIV infection related PAH are eligible but subjects with congenital heart disease and pediatric subjects are excluded. The study requires a historical cardiac catheterization and other diagnostic procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
186
Change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo.
Change from baseline measured after 12 weeks of treatment compared to placebo in the Borg Dyspnea Index; WHO Functional Classification; and the SF-36 Health Survey.
Clinical worsening of PAH.
Assessment of the safety and tolerability of the study drug.
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