Pulmonary HypertensionPhase 3NCT00091598
ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)
A Phase 3 study testing Ambrisentan in people with Pulmonary Hypertension, run by Gilead Sciences at 46 sites in 3 countries.
Trial summary
The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Ambrisentan
- How many people
- 372 participants
- Where
- 46 sitesin 3 countries
- Study dates
- Jan 2004to Feb 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
46 sites in 3 countries.
46 sites in 3 countries
United States44 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
Medical College of Georgia
Augusta, Georgia, 30912
Johns Hopkins University
Baltimore, Maryland, 21205
Tufts New England Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22908
Loyola University Medical Center
Chicago, Illinois, 60153
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
St. Paul Hospital
Dallas, Texas, 75235
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Wayne State University
Detroit, Michigan, 48201
University of Connecticut Health Center
Farmington, Connecticut, 06030
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Brentwood Biomedical Research Institute
Los Angeles, California, 90073
Northshore University/Long Island Jewish Hospital
Manhasset, New York, 11030
Mt. Sinai Medical Center
Miami, Florida, 33140
Heart Care Associates
Milwaukee, Wisconsin, 53215
Winthrop University Hospital
Mineola, New York, 11501
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Ochsner Clinic
New Orleans, Louisiana, 70121
Mt. Sinai Medical Center
New York, New York, 10029
New York Presbyterian Hospital
New York, New York, 10032
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Pulmonary Associates, PA
Phoenix, Arizona, 85006
Arizona Pulmonary Specialists
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Maine Medical Center
Portland, Maine, 04102
Oregon Health Sciences University
Portland, Oregon, 97202
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of California-Davis
Sacramento, California, 95817
University of Texas - San Antonio
San Antonio, Texas, 78229
University of California San Diego Medical Center
San Diego, California, 92037
Washington University
St Louis, Missouri, 63110
Cardiology PC
Syracuse, New York, 13210
Scott & White Hospital
Temple, Texas, 76508
Los Angeles County Harbor-UCLA Medical Center
Torrance, California, 90502
Myogen
Westminster, Colorado, 80021
About this study
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
The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Ambrisentan
- Keywords
- Pulmonary Arterial Hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbrisentanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at Week 12 of six minute walk distance
Secondary outcomes (5)
Change from baseline at Week 12 of:
Borg Dsypnea Index
WHO Functional Classification
SF-36
Time to Clinical Worsening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2004 (estimated)
- Study startJan 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 372 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lewis J. Rubin, MD, Study chair, University of California San Diego, San Diego School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091598
- Sponsor's protocol ID
- ARIES
- Status last verified
- Mar 2010
- First submitted
- 10 Sep 2004
- Last updated
- 8 Mar 2010
- Results posted
- No
- Expanded access
- Available
Publications
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.
PubMed 18506008
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00091598
- Acronym / sponsor ID
- ARIES
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 14 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambrisentan | Drug | – |
Primary outcome
Change from baseline at Week 12 of six minute walk distance
5 secondary outcomes
Change from baseline at Week 12 of:
Borg Dsypnea Index
WHO Functional Classification
SF-36
Time to Clinical Worsening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2010.
- Derived from this study: PubMed 18506008Galie 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.
- Pulmonary Hypertension AssociationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis J. Rubin, MD study chair
University of California San Diego, San Diego School of Medicine
46 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ambrisentan in people with Pulmonary Hypertension, run by Gilead Sciences at 46 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline at Week 12 of six minute walk distance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2010.