DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
Stopped early · Phase 3
Conditions studied: Hypertension
In brief
This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.
Key facts
- Study ID
- NCT00353574
- Run by
- Gilead Sciences
- People needed
- 282
- Starts
- 2006-09-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2014-03-18
Who can join
Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects who have completed the Treatment Period of clinical trial DAR-311
- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
You may not qualify if…
- Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE)
- Treatment with another endothelin receptor antagonist within 6 months of study entry
Where it is running
- Canyon Clinical Research — Tucson, Arizona, United States
- Chrishard Medical Group — Inglewood, California, United States
- VA Medical Center - WLA — Los Angeles, California, United States
- Sacramento Heart and Vascular — Sacramento, California, United States
- Apex Research Institute — Santa Ana, California, United States
- Complete Renal Care — Denver, Colorado, United States
- Connecticut Clinical Research, LLC — Bridgeport, Connecticut, United States
- MedStar Diabetes Institute at Washington Hospital Center — Washington D.C., District of Columbia, United States
- White-Wilson Medical Center — Fort Walton Beach, Florida, United States
- A.G.A. Clinical Trials — Hialeah, Florida, United States
- Jacksonville Center for Clinical — Jacksonville, Florida, United States
- Ricardo A. Bedoya, Cardiology — Jupiter, Florida, United States
- International Research Association — Miami, Florida, United States
- Cardiovascular Center of Sarasota — Sarasota, Florida, United States
- Tampa Bay Nephrology Associates, PL — Tampa, Florida, United States
- Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
- Global Research Partners — Calhoun, Georgia, United States
- Kula Research — Honolulu, Hawaii, United States
- Chicago Heart & Vein Clinic — Elk Grove Village, Illinois, United States
- Evanston Northwestern Healthcare — Evanston, Illinois, United States
- Clinical Investigation Specialists, Inc. — Gurnee, Illinois, United States
- Midwest Heart Foundation — Lombard, Illinois, United States
- Medical Research Institute — Slidell, Louisiana, United States
- Androscoggin Cardiology Associates — Auburn, Maine, United States
- Comprehensive Heart Failure Center — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.