ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)
- Conditions
- Pulmonary Hypertension
- Registration Number
- NCT00091598
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
- Diagnosis of idiopathic PAH (formally known as PPH), or PAH associated with collagen vascular disease, anorexigen use, or HIV infection;
- 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;
- Portopulmonary hypertension;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline at Week 12 of six minute walk distance
- Secondary Outcome Measures
Name Time Method Change from baseline at Week 12 of: Borg Dsypnea Index WHO Functional Classification SF-36 Time to Clinical Worsening
Trial Locations
- Locations (45)
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Brentwood Biomedical Research Institute
🇺🇸Los Angeles, California, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Northshore University/Long Island Jewish Hospital
🇺🇸Manhasset, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
St. Paul Hospital
🇺🇸Dallas, Texas, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Pulmonary Associates, PA
🇺🇸Phoenix, Arizona, United States
Arizona Pulmonary Specialists
🇺🇸Phoenix, Arizona, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Myogen
🇺🇸Westminster, Colorado, United States
Los Angeles County Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Tufts New England Medical Center
🇺🇸Boston, Massachusetts, United States
St. Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
Scott & White Hospital
🇺🇸Temple, Texas, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas - San Antonio
🇺🇸San Antonio, Texas, United States
Heart Care Associates
🇺🇸Milwaukee, Wisconsin, United States
Mt. Sinai Medical Center
🇺🇸New York City, New York, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Loyola University Medical Center
🇺🇸Chicago, Illinois, United States
University of California-Davis
🇺🇸Sacramento, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cardiology PC
🇺🇸Syracuse, New York, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States