DORADO-AC – Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312)
Myogen, Inc.
800 participants
Jan 1, 2007
Interventional
Conditions
Summary
This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose: 50, 100, or 300 mg qd), an active comparator (guanfacine 1 mg qd), or placebo, administered orally. The study drug will be titrated to an optimized dose at which predefined blood pressure criteria are achieved. The treatment period for this trial is 14 weeks.
Eligibility
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Interventions
This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose: 50, 100, or 300 mg qd), an active comparator (guanfacine 1 mg qd), administered orally. The study drug will be titrated to an optimized dose at which predefined blood pressure criteria are achieved. The treatment period for this trial is 14 weeks.
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ACTRN12606000446561