Status:
COMPLETED
ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
Gilead Sciences
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00091598
Start Date
January 1 2004
End Date
February 1 2006
Last Update
March 8 2010
Active Locations (46)
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1
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
2
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85013
3
Brentwood Biomedical Research Institute
Los Angeles, California, United States, 90073
4
University of California-Davis
Sacramento, California, United States, 95817