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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:
United States, Arizona | |
Pulmonary Associates, PA | |
Phoenix, Arizona, United States, 85006 | |
Arizona Pulmonary Specialists | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
University of California-Davis | |
Sacramento, California, United States, 95817 | |
Los Angeles County Harbor-UCLA Medical Center | |
Torrance, California, United States, 90502 | |
University of California San Diego Medical Center | |
San Diego, California, United States, 92037 | |
Brentwood Biomedical Research Institute | |
Los Angeles, California, United States, 90073 | |
United States, Colorado | |
Myogen | |
Westminster, Colorado, United States, 80021 | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80262 | |
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030 | |
United States, Florida | |
Mt. Sinai Medical Center | |
Miami, Florida, United States, 33140 | |
United States, Georgia | |
Medical College of Georgia | |
Augusta, Georgia, United States, 30912 | |
Emory University Hospital | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Loyola University Medical Center | |
Chicago, Illinois, United States, 60153 | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 | |
United States, Louisiana | |
Ochsner Clinic | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maine | |
Maine Medical Center | |
Portland, Maine, United States, 04102 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Tufts New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, Michigan | |
University of Michigan Medical Center | |
Ann Arbor, Michigan, United States, 48109 | |
Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
New York Presbyterian Hospital | |
New York, New York, United States, 10032 | |
Cardiology PC | |
Syracuse, New York, United States, 13210 | |
Winthrop University Hospital | |
Mineola, New York, United States, 11501 | |
Mt. Sinai Medical Center | |
New York City, New York, United States, 10029 | |
Northshore University/Long Island Jewish Hospital | |
Manhasset, New York, United States, 11030 | |
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
Lindner Clinical Trial Center | |
Cincinnati, Ohio, United States, 45219 | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Oregon Health Sciences University | |
Portland, Oregon, United States, 97202 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 | |
University of Pennsylvania Hospital | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
St. Paul Hospital | |
Dallas, Texas, United States, 75235 | |
Scott & White Hospital | |
Temple, Texas, United States, 76508 | |
University of Texas - San Antonio | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 | |
University of Virginia Health System | |
Charlottesville, Virginia, United States, 22908 | |
United States, Wisconsin | |
Heart Care Associates | |
Milwaukee, Wisconsin, United States, 53215 | |
Australia, New South Wales | |
St. Vincent's Hospital | |
Sydney, New South Wales, Australia, 2010 | |
Canada, Quebec | |
Jewish General Hospital | |
Montreal, Quebec, Canada, H3T1E2 |
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 |