Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
NCT ID: NCT00380068
Last Updated: 2012-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
224 participants
INTERVENTIONAL
2006-08-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ambrisentan
Ambrisentan
Oral tablets taken once daily.
Interventions
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Ambrisentan
Oral tablets taken once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Current diagnosis of PH associated with an acceptable etiology as outlined in the protocol, including: PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1); 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHO Group 5).
3. Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calcium channel blocker, or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor therapy
4. Right heart catheterization completed prior to screening must meet pre-specified criteria
5. Female participants of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double method of contraception until study completion and for at least four weeks following their final study visit.
6. Male participants must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form.
Exclusion Criteria
2. Bosentan or sitaxsentan use within four weeks prior to the screening visit
3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is greater than 3 times the upper limit of normal at the screening visit
4. Pulmonary function tests not meeting the following pre-specified criteria: 1) mean pulmonary arterial pressure (PAP) \>= 25 mm Hg; 2) PVR \> 3 mm Hg/L/min; 3) pulmonary capillary wedge pressure (PCWP) or left ventricle end diastolic pressure (LVEDP) \< 15 mm Hg; 4) total lung capacity (TLC) \>= 70% of predicted normal for participants without ILD or \>= 60% of predicted normal in participants with ILD; forced expiratory volume in 1 second (FEV1) \>= 65% of predicted normal in participants without COPD or \>= 50% of predicted normal in participants with COPD
5. Contraindication to treatment with endothelin receptor antagonist (ERA)
6. History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years
7. Female participant who is pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Lewis J Rubin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialists, Ltd
Phoenix, Arizona, United States
UCSD Medical Center, Thornton Hospital
La Jolla, California, United States
Greater Los Angeles, VA Medical Center
Los Angeles, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Pulmonary Hypertension Clinic Mount Sinai Medical Center
Miami Beach, Florida, United States
Suncoast Lung Center
Sarasota, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, United States
University of Chicago Hospitals
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 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
Boston Adult Congenital Heart Service
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Medicine & Dentistry of New Jersey
Newark, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
New York Presbyterian Pulmonary Hypertension Center
New York, New York, United States
Mary Parkes Asthma Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Legacy Clinical Northwest
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Presbyterian
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Lexington Pulmonary and Critical Care
Lexington, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia Health Sciences Center
Charlottesville, Virginia, United States
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Royal Perth Hospital
Perth, , Australia
Peter Lougheed Centre
Calgary, Alberta, Canada
University of Alberta Hospitals
Edmonton, Alberta, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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ARIES-3
Identifier Type: -
Identifier Source: secondary_id
AMB-323
Identifier Type: -
Identifier Source: org_study_id
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