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ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)

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, Study Chair, Affiliation: University of California San Diego, San Diego School of Medicine

Summary

The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.

Clinical Details

Official title: ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline at Week 12 of six minute walk distance

Secondary outcome:

Change from baseline at Week 12 of:

Borg Dsypnea Index

WHO Functional Classification

SF-36

Time to Clinical Worsening

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.

Eligibility

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

Criteria:

Inclusion Criteria:

- 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; Exclusion Criteria:

- 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.

Locations and Contacts

Arizona Pulmonary Specialists, Phoenix, Arizona 85013, United States

Pulmonary Associates, PA, Phoenix, Arizona 85006, United States

Brentwood Biomedical Research Institute, Los Angeles, California 90073, United States

University of California-Davis, Sacramento, California 95817, United States

University of California San Diego Medical Center, San Diego, California 92037, United States

Los Angeles County Harbor-UCLA Medical Center, Torrance, California 90502, United States

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States

Myogen, Westminster, Colorado 80021, United States

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

Mt. Sinai Medical Center, Miami, Florida 33140, United States

Emory University Hospital, Atlanta, Georgia 30322, United States

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

Loyola University Medical Center, Chicago, Illinois 60153, United States

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

Ochsner Clinic, New Orleans, Louisiana 70121, United States

Maine Medical Center, Portland, Maine 04102, United States

Johns Hopkins University, Baltimore, Maryland 21205, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

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

University of Michigan Medical Center, Ann Arbor, Michigan 48109, United States

Wayne State University, Detroit, Michigan 48201, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Washington University, St. Louis, Missouri 63110, United States

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

Northshore University/Long Island Jewish Hospital, Manhasset, New York 11030, United States

Winthrop University Hospital, Mineola, New York 11501, United States

Mt. Sinai Medical Center, New York City, New York 10029, United States

New York Presbyterian Hospital, New York, New York 10032, United States

Cardiology PC, Syracuse, New York 13210, United States

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

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

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

Oregon Health Sciences University, Portland, Oregon 97202, United States

University of Pennsylvania Hospital, Philadelphia, Pennsylvania 19104, United States

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

Jewish General Hospital, Montreal, Quebec H3T1E2, Canada

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

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

St. Paul Hospital, Dallas, Texas 75235, United States

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

University of Texas - San Antonio, San Antonio, Texas 78229, United States

Scott & White Hospital, Temple, Texas 76508, United States

University of Virginia Health System, Charlottesville, Virginia 22908, United States

Virginia Commonwealth University, Richmond, Virginia 23298, United States

Heart Care Associates, Milwaukee, Wisconsin 53215, United States

Additional Information

Pulmonary Hypertension Association

Starting date: January 2004
Last updated: March 4, 2010

Page last updated: August 23, 2015

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