DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
- Registration Number
- NCT00353574
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 282
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darusentan 50 mg Darusentan Darusentan 50 mg administered orally once daily Darusentan 100 mg Darusentan Darusentan 100 mg administered orally once daily Darusentan 300 mg Darusentan Darusentan 300 mg administered orally once daily
- Primary Outcome Measures
Name Time Method Change in trough sitting systolic and diastolic blood pressure Baseline to Week 14
- Secondary Outcome Measures
Name Time Method Change in mean 24-hour systolic and diastolic ambulatory blood pressures. Baseline to Week 14 Percentage of subjects who reach systolic blood pressure goal Week 14 Change in estimated glomerular filtration rate (eGFR) Baseline to Week 14
Trial Locations
- Locations (74)
Comprehensive Heart Failure Center
🇺🇸Mobile, Alabama, United States
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, District of Columbia, United States
White-Wilson Medical Center
🇺🇸Fort Walton Beach, Florida, United States
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