ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT00091598
Last Updated: 2010-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
372 participants
INTERVENTIONAL
2004-01-31
2006-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Ambrisentan
Eligibility Criteria
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Inclusion Criteria
* Historical cardiac catheterization with the following hemodynamic 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;
* 6-minute walk distance of at least 150 meters, but no more than 450 meters;
* Total lung capacity greater than or equal to 70% and FEV1 greater than or equal to 65% of predicted normal;
Exclusion Criteria
* Subjects with PAH due to or associated with coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thromboembolic disease, or sleep apnea;
* Bosentan (Tracleer®), sildenafil (Viagra®), or chronic prostanoid therapy within 4 weeks of screening;
* Serum ALT or AST lab value that is greater than 1.5 times the upper limit of normal;
* Contraindication to treatment with an endothelin receptor antagonist;
* Subject with cardiovascular, hepatic, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that may adversely affect the safety of the subject;
* Participation in a clinical study involving another investigational drug within 4 weeks of screening.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Principal Investigators
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Lewis J. Rubin, MD
Role: STUDY_CHAIR
University of California San Diego, San Diego School of Medicine
Locations
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Pulmonary Associates, PA
Phoenix, Arizona, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
Brentwood Biomedical Research Institute
Los Angeles, California, United States
University of California-Davis
Sacramento, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Myogen
Westminster, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Mt. Sinai Medical Center
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Loyola University Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts New England Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Northshore University/Long Island Jewish Hospital
Manhasset, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Mt. Sinai Medical Center
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Cardiology PC
Syracuse, New York, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
St. Paul Hospital
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas - San Antonio
San Antonio, Texas, United States
Scott & White Hospital
Temple, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Heart Care Associates
Milwaukee, Wisconsin, United States
St. Vincent's Hospital
Sydney, New South Wales, Australia
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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References
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Galie N, Olschewski H, Oudiz RJ, Torres F, Frost A, Ghofrani HA, Badesch DB, McGoon MD, McLaughlin VV, Roecker EB, Gerber MJ, Dufton C, Wiens BL, Rubin LJ; Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies (ARIES) Group. Ambrisentan for the treatment of pulmonary arterial hypertension: results of the ambrisentan in pulmonary arterial hypertension, randomized, double-blind, placebo-controlled, multicenter, efficacy (ARIES) study 1 and 2. Circulation. 2008 Jun 10;117(23):3010-9. doi: 10.1161/CIRCULATIONAHA.107.742510. Epub 2008 May 27.
Related Links
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Pulmonary Hypertension Association
Other Identifiers
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ARIES
Identifier Type: -
Identifier Source: org_study_id
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