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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00091598 |
The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Hypertension |
Drug: Ambrisentan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 372 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | February 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Mean pulmonary artery pressure greater than or equal to 25 mmHg; Pulmonary vascular resistance greater than 3 mmHg/L/min; Pulmonary capillary wedge pressure or left ventricular end diastolic pressure less than 15 mmHg;
Exclusion Criteria:
Study Chair: | Lewis J. Rubin, MD | University of California San Diego, San Diego School of Medicine |
Study ID Numbers: | ARIES |
Study First Received: | September 10, 2004 |
Last Updated: | January 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00091598 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pulmonary Arterial Hypertension |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Idiopathic Pulmonary Hypertension Vascular Diseases Hypertension |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Vascular Diseases Cardiovascular Diseases Hypertension |