DORADO – Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension
DORADO – A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Four or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)
Myogen, inc.
350 participants
Sep 1, 2006
Interventional
Conditions
Summary
This is a placebo-controlled research study of a new experimental drug called darusentan. Darusentan is not currently approved by the Therapeutic Goods Administration (TGA) for use in Australia, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of four or more antihypertensive drugs, including a diuretic. Subjects will be randomized to one of three doses of darusentan (50, 100, or 300 mg qd) versus placebo administered orally. The treatment period for this trial is 14 weeks.
Eligibility
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Interventions
This is a randomized, double-blind, placebo-controlled research study of a new experimental drug called darusentan. Darusentan is not currently approved by the Therapeutic Goods Administration (TGA) for use in Australia, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of four or more antihypertensive drugs, including a diuretic. Subjects will be randomized to one of three doses of darusentan (50, 100, or 300 mg qd) administered orally. The treatment period for this trial is 14 weeks.
Locations(1)
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ACTRN12606000292572