April 03, 2009
Phase 3 study of darusentan for resistant hypertensionGilead Sciences announced the results of one of its two Phase 3 trials evaluating darusentan to treat resistant hypertension. This trial, named DORADO (or DAR-311), met its co-primary efficacy endpoints of change from baseline to week 14 in trough sitting systolic blood pressure (SBP) and trough sitting diastolic blood pressure (DBP). DORADO is a double-blind, placebo-controlled parallel group trial, in which 379 patients were randomized to receive once-daily doses of darusentan 50 mg (n=81), 100 mg (n=81), 300 mg (n=85) or placebo (n=132).
Darusentan is a propanoic-acid class endothelin receptor antagonist (ERA) being investigated as an add-on oral therapy for patients with resistant hypertension. Darusentan selectively blocks the endothelin type-A (ETA) receptor, which if activated by endothelin-1 (ET-1), leads to vasoconstriction and cell proliferation. Elevated ET-1 blood concentrations have been reported in some hypertensive patients, including several subgroups of patients that have been historically difficult to treat.
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