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Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: Ambrisentan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Lewis J Rubin, MD, Principal Investigator, Affiliation: University of California, San Diego

Summary

The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in a broad population of participants with pulmonary hypertension (PH). Secondary objectives of this study were to evaluate the effects of ambrisentan on other clinical measures of pulmonary arterial hypertension (PAH), long-term treatment success, and survival.

Clinical Details

Official title: ARIES-3: A Phase 3, Long-Term, Open-Label, Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)

Secondary outcome:

Change From Baseline to Week 24 in Borg Dyspnea Index

Change From Baseline to Week 48 in Borg Dyspnea Index

Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP)

Percent Change From Baseline to Week 48 in BNP

Change From Baseline to Week 24 in WHO Functional Class

Change From Baseline to Week 48 in WHO Functional Class

Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale

Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale

Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24

Percent of Participants With no Clinical Worsening of PH at Week 48

Failure-free Treatment Status

Failure-free Treatment Status

Monotherapy Treatment Status

Monotherapy Treatment Status

Long-term Survival

Long-term Survival

Detailed description: This study was to enroll up to 200 participants with 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). Participants with left heart disease or left heart failure were excluded (WHO Group 2). Participants could be receiving prostacyclin or sildenafil therapy at baseline, and participants who previously discontinued either bosentan, sitaxsentan, or both, due to liver function test abnormalities were eligible.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Summarized Inclusion Criteria: 1. 18 years of age or older 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. Summarized Exclusion Criteria: 1. Participation in a previous clinical study with ambrisentan 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

Locations and Contacts

Royal Perth Hospital, Perth 6000, Australia

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Peter Lougheed Centre, Calgary, Alberta T1Y 6J4, Canada

University of Alberta Hospitals, Edmonton, Alberta T6G 2B7, Canada

Arizona Pulmonary Specialists, Ltd, Phoenix, Arizona 85013, United States

UCSD Medical Center, Thornton Hospital, La Jolla, California 92037, United States

Greater Los Angeles, VA Medical Center, Los Angeles, California 90073, United States

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California 90502, United States

University of Colorado Health Sciences Center, Aurora, Colorado 80045, United States

University of Connecticut Health Center, Farmington, Connecticut 06030, United States

Pulmonary Hypertension Clinic Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Suncoast Lung Center, Sarasota, Florida 34233, United States

Medical College of Georgia, Augusta, Georgia 30912, United States

Atlanta Institute for Medical Research, Inc., Decatur, Georgia 30030, United States

University of Chicago Hospitals, Chicago, Illinois 60637, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

Johns Hopkins University, Baltimore, Maryland 21287, United States

Boston Adult Congenital Heart Service, Boston, Massachusetts 02115, United States

Boston University School of Medicine, Boston, Massachusetts 02118, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Tufts-New England Medical Center, Boston, Massachusetts 02111, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

University of Medicine & Dentistry of New Jersey, Newark, New Jersey 07103, United States

St. Vincent's Hospital, Darlinghurst, New South Wales 2010, Australia

New York Presbyterian Pulmonary Hypertension Center, New York, New York 10032, United States

Mary Parkes Asthma Center, Rochester, New York 14623, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

The Lindner Clinical Trial Center, Cincinnati, Ohio 45219, United States

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Toronto General Hospital, Toronto, Ontario M5G 2N2, Canada

Legacy Clinical Northwest, Portland, Oregon 97210, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

University of Pittsburgh Medical Center Presbyterian, Pittsburgh, Pennsylvania 15213, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Lexington Pulmonary and Critical Care, Lexington, South Carolina 29072, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Virginia Health Sciences Center, Charlottesville, Virginia 22908, United States

Additional Information

Starting date: August 2006
Last updated: April 2, 2012

Page last updated: August 23, 2015

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