Status:
TERMINATED
DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
Lead Sponsor:
Gilead Sciences
Conditions:
Hypertension
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief Summary
This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in not currently approved by the United States Food and Drug Administration (FDA), w...
Eligibility Criteria
Inclusion
- SELECTED INCLUSION CRITERIA:
- Subjects must be competent to provide written informed consent;
- Subjects must have completed the Maintenance Period of the DAR-312 study.
- SELECTED EXCLUSION CRITERIA:
- Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE;
- Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
661 Patients enrolled
Trial Details
Trial ID
NCT00389675
Start Date
May 1 2007
End Date
May 1 2010
Last Update
January 6 2014
Active Locations (99)
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1
Alabama Internal Medicine, PC
Birmingham, Alabama, United States, 35235
2
Greystone Medical Research, LLC
Birmingham, Alabama, United States, 35242
3
The Heart Center, PC
Huntsville, Alabama, United States, 35801
4
Mulberry Medical Associates, PC
Montgomery, Alabama, United States, 36106