ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)
The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.
Gilead Sciences has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension|
- Change from baseline at Week 12 of six minute walk distance
- Change from baseline at Week 12 of:
- Borg Dsypnea Index
- WHO Functional Classification
- Time to Clinical Worsening
|Study Start Date:||January 2004|
|Study Completion Date:||February 2006|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
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.
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|Study Chair:||Lewis J. Rubin, MD||University of California San Diego, San Diego School of Medicine|