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

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00091598
First received: September 10, 2004
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Pulmonary Hypertension
Drug: Ambrisentan
Phase 3

Gilead Sciences has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change from baseline at Week 12 of six minute walk distance

Secondary Outcome Measures:
  • Change from baseline at Week 12 of:
  • Borg Dsypnea Index
  • WHO Functional Classification
  • SF-36
  • Time to Clinical Worsening

Estimated Enrollment: 372
Study Start Date: January 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091598

  Hide Study Locations
Locations
United States, Arizona
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85013
United States, California
Brentwood Biomedical Research Institute
Los Angeles, California, United States, 90073
University of California-Davis
Sacramento, California, United States, 95817
University of California San Diego Medical Center
San Diego, California, United States, 92037
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
Myogen
Westminster, Colorado, United States, 80021
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
Mt. Sinai Medical Center
Miami, Florida, United States, 33140
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Loyola University Medical Center
Chicago, Illinois, United States, 60153
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Northshore University/Long Island Jewish Hospital
Manhasset, New York, United States, 11030
Winthrop University Hospital
Mineola, New York, United States, 11501
New York Presbyterian Hospital
New York, New York, United States, 10032
Mt. Sinai Medical Center
New York City, New York, United States, 10029
Cardiology PC
Syracuse, New York, United States, 13210
United States, Ohio
Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97202
United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
St. Paul Hospital
Dallas, Texas, United States, 75235
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas - San Antonio
San Antonio, Texas, United States, 78229
Scott & White Hospital
Temple, Texas, United States, 76508
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Heart Care Associates
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Chair: Lewis J. Rubin, MD University of California San Diego, San Diego School of Medicine
  More Information

Additional Information:
No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00091598     History of Changes
Other Study ID Numbers: ARIES
Study First Received: September 10, 2004
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014