The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.
ARIES-1 in North America and Australia ARIES-2 in Western and Eastern Europe, South America and Israel 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
372
Change from baseline at Week 12 of six minute walk distance
Change from baseline at Week 12 of:
Borg Dsypnea Index
WHO Functional Classification
SF-36
Time to Clinical Worsening
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