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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ambrisentan
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pulmonary Associates, PA
  • Arizona Pulmonary Specialists
  • Brentwood Biomedical Research Institute
  • University of California-Davis
  • University of California San Diego Medical Center
  • Los Angeles County Harbor-UCLA Medical Center
  • University of Colorado Health Sciences Center
  • Myogen
  • University of Connecticut Health Center
  • Mt. Sinai Medical Center
  • Emory University Hospital
  • Medical College of Georgia
  • Loyola University Medical Center
  • University of Iowa Hospitals and Clinics
  • Ochsner Clinic
  • Maine Medical Center
  • Johns Hopkins University
  • Tufts New England Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • University of Michigan Medical Center
  • Wayne State University
  • Mayo Clinic
  • Washington University
  • Northshore University/Long Island Jewish Hospital
  • Winthrop University Hospital
  • Mt. Sinai Medical Center
  • New York Presbyterian Hospital
  • Cardiology PC
  • Lindner Clinical Trial Center
  • University Hospitals of Cleveland
  • Cleveland Clinic Foundation
  • Oregon Health Sciences University
  • University of Pennsylvania Hospital
  • University of Pittsburgh Medical Center
  • Rhode Island Hospital
  • Vanderbilt University Medical Center
  • St. Paul Hospital
  • Baylor College of Medicine
  • University of Texas - San Antonio
  • Scott & White Hospital
  • University of Virginia Health System
  • Virginia Commonwealth University
  • Heart Care Associates
  • St. Vincent's Hospital
  • Jewish General Hospital

Outcomes

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

Full Information

First Posted
September 10, 2004
Last Updated
March 4, 2010
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00091598
Brief Title
ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
372 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ambrisentan
Primary Outcome Measure Information:
Title
Change from baseline at Week 12 of six minute walk distance
Secondary Outcome Measure Information:
Title
Change from baseline at Week 12 of:
Title
Borg Dsypnea Index
Title
WHO Functional Classification
Title
SF-36
Title
Time to Clinical Worsening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis J. Rubin, MD
Organizational Affiliation
University of California San Diego, San Diego School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Pulmonary Associates, PA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arizona Pulmonary Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Brentwood Biomedical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Los Angeles County Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Myogen
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80021
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Mt. Sinai Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Loyola University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Northshore University/Long Island Jewish Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York City
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cardiology PC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
St. Paul Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott & White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Heart Care Associates
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18506008
Citation
Galie N, Olschewski H, Oudiz RJ, Torres F, Frost A, Ghofrani HA, Badesch DB, McGoon MD, McLaughlin VV, Roecker EB, Gerber MJ, Dufton C, Wiens BL, Rubin LJ; Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies (ARIES) Group. Ambrisentan for the treatment of pulmonary arterial hypertension: results of the ambrisentan in pulmonary arterial hypertension, randomized, double-blind, placebo-controlled, multicenter, efficacy (ARIES) study 1 and 2. Circulation. 2008 Jun 10;117(23):3010-9. doi: 10.1161/CIRCULATIONAHA.107.742510. Epub 2008 May 27.
Results Reference
derived
Links:
URL
http://www.phassociation.org
Description
Pulmonary Hypertension Association

Learn more about this trial

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

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