Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)
Completed · Phase 4 · Has a placebo group
Conditions studied: Pulmonary Arterial Hypertension
In brief
To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who have demonstrated a sub-optimal response to PDE-5i monotherapy. The study was originally designed as a 2-arm, double-blind, randomized study in which patients received ambrisentan or placebo for 24 weeks, and then received ambrisentan blinded to dose for 24 weeks. With Protocol Amendment 2 (12 June, 2009), the study was switched to single-arm, open-label treatment, and all patients remaining in the placebo arm were switched to open-label ambrisentan treatment. Patients who enrolled after Amendment 2 all received open-label ambrisentan.
Key facts
- Study ID
- NCT00617305
- Run by
- Gilead Sciences
- People needed
- 38
- Starts
- 2008-04-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2012-07-30
Who can join
Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of South Alabama — Mobile, Alabama, United States
- Arizona Pulmonary Specialists — Phoenix, Arizona, United States
- West Los Angeles Healthcare Center — Los Angeles, California, United States
- Harbor - UCLA — Torrance, California, United States
- Cleveland Clinic — Fort Lauderdale, Florida, United States
- University of Florida — Gainesville, Florida, United States
- Mount Sinai Medical Center — Miami Beach, Florida, United States
- Orlando Heart Center — Orlando, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Atlanta Institute for Medical Research — Decatur, Georgia, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Maryland — Baltimore, Maryland, United States
- BACH Cardiology — Boston, Massachusetts, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- Wayne State University — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Weill Cornell Medical Center — New York, New York, United States
- Asheville Cardiology Associates — Asheville, North Carolina, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
- University Hospitals of Cleveland — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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