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

Completed · Phase 3

Conditions studied: Pulmonary Hypertension

In brief

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

Key facts

Study ID

NCT00091598

Run by

Gilead Sciences

People needed

372

Starts

2004-01-01

Expected to finish

2006-02-01

Last updated by the study team

2010-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• Arizona Pulmonary Specialists — Phoenix, Arizona, United States
• Brentwood Biomedical Research Institute — Los Angeles, California, United States
• University of California-Davis — Sacramento, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• Los Angeles County Harbor-UCLA Medical Center — Torrance, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Myogen — Westminster, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Mt. Sinai Medical Center — Miami, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Loyola University Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Tufts New England Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Northshore University/Long Island Jewish Hospital — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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