Phase
Condition
Williams Syndrome
Stress
Scleroderma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Summarized Inclusion Criteria:
18 years of age or older
Current diagnosis of PH associated with an acceptable etiology as outlined in theprotocol, including: PH due to the following etiologies: 1) PAH including idiopathicand familial PAH and PAH associated with collagen vascular disease, congenitalsystemic-to-pulmonary shunts (including Eisenmenger's syndrome), humanimmunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogenstorage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1);
- PH associated with lung diseases and/or hypoxemia, including chronic obstructivepulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing,and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distalchronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHOGroup 5).
Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calciumchannel blocker, or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductaseinhibitor therapy
Right heart catheterization completed prior to screening must meet pre-specifiedcriteria
Female participants of childbearing potential must have a negative serum pregnancytest and must agree to use a reliable double method of contraception until studycompletion and for at least four weeks following their final study visit.
Male participants must be informed of the potential risks of testicular tubularatrophy and infertility associated with taking ambrisentan and queried regarding hisunderstanding of the potential risks as described in the Informed Consent Form.
Exclusion
Summarized Exclusion Criteria:
Participation in a previous clinical study with ambrisentan
Bosentan or sitaxsentan use within four weeks prior to the screening visit
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that isgreater than 3 times the upper limit of normal at the screening visit
Pulmonary function tests not meeting the following pre-specified criteria: 1) meanpulmonary arterial pressure (PAP) >= 25 mm Hg; 2) PVR > 3 mm Hg/L/min; 3) pulmonarycapillary wedge pressure (PCWP) or left ventricle end diastolic pressure (LVEDP) < 15mm Hg; 4) total lung capacity (TLC) >= 70% of predicted normal for participantswithout ILD or >= 60% of predicted normal in participants with ILD; forced expiratoryvolume in 1 second (FEV1) >= 65% of predicted normal in participants without COPD or >= 50% of predicted normal in participants with COPD
Contraindication to treatment with endothelin receptor antagonist (ERA)
History of malignancies other than basal cell carcinoma of the skin or in situcarcinoma of the cervix within the past five years
Female participant who is pregnant or breastfeeding
Study Design
Study Description
Connect with a study center
St. Vincent's Hospital
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Royal Perth Hospital
Perth, 6000
AustraliaSite Not Available
Peter Lougheed Centre
Calgary, Alberta T1Y 6J4
CanadaSite Not Available
University of Alberta Hospitals
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
London Health Sciences Centre, Victoria Hospital
London, Ontario N6A 4W9
CanadaSite Not Available
Toronto General Hospital
Toronto, Ontario M5G 2N2
CanadaSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Arizona Pulmonary Specialists, Ltd
Phoenix, Arizona 85013
United StatesSite Not Available
UCSD Medical Center, Thornton Hospital
La Jolla, California 92037
United StatesSite Not Available
Greater Los Angeles, VA Medical Center
Los Angeles, California 90073
United StatesSite Not Available
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
University of Colorado Health Sciences Center
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Health Science Center
Denver, Colorado 80262
United StatesSite Not Available
University of Connecticut Health Center
Farmington, Connecticut 06030
United StatesSite Not Available
Yale University School of Medicine
New Haven, Connecticut 06520
United StatesSite Not Available
Pulmonary Hypertension Clinic Mount Sinai Medical Center
Miami Beach, Florida 33140
United StatesSite Not Available
Suncoast Lung Center
Sarasota, Florida 34233
United StatesSite Not Available
Medical College of Georgia
Augusta, Georgia 30912
United StatesSite Not Available
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia 30030
United StatesSite Not Available
University of Chicago Hospitals
Chicago, Illinois 60637
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Johns Hopkins University
Baltimore, Maryland 21287
United StatesSite Not Available
Boston Adult Congenital Heart Service
Boston, Massachusetts 02115
United StatesSite Not Available
Boston University School of Medicine
Boston, Massachusetts 02118
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Tufts-New England Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Wayne State University
Detroit, Michigan 48201
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
St. Louis, Missouri 63110
United StatesSite Not Available
UMDNJ Scleroderma Program
New Brunswick, New Jersey 08903
United StatesSite Not Available
Newark Beth Israel Medical Center
Newark, New Jersey 07112
United StatesSite Not Available
University of Medicine & Dentistry of New Jersey
Newark, New Jersey 07103
United StatesSite Not Available
New York Presbyterian Pulmonary Hypertension Center
New York, New York 10032
United StatesSite Not Available
Mary Parkes Asthma Center
Rochester, New York 14623
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
The Lindner Clinical Trial Center
Cincinnati, Ohio 45219
United StatesSite Not Available
University Hospitals of Cleveland
Cleveland, Ohio 44106
United StatesSite Not Available
Legacy Clinical Northwest
Portland, Oregon 97210
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
University of Pittsburgh Medical Center Presbyterian
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesSite Not Available
Lexington Pulmonary and Critical Care
Lexington, South Carolina 29072
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Uthsc-Sa
San Antonio, Texas 78229
United StatesSite Not Available
University of Virginia Health Sciences Center
Charlottesville, Virginia 22908
United StatesSite Not Available
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