Status:
TERMINATED
DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
Lead Sponsor:
Gilead Sciences
Conditions:
Hypertension
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
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 me...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00353574
Start Date
September 1 2006
End Date
April 1 2010
Last Update
March 18 2014
Active Locations (75)
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1
Comprehensive Heart Failure Center
Mobile, Alabama, United States, 36608
2
Canyon Clinical Research
Tucson, Arizona, United States, 85712
3
Chrishard Medical Group
Inglewood, California, United States, 90301
4
VA Medical Center - WLA
Los Angeles, California, United States, 90073