Not Yet RecruitingPhase 3ACTRN12606000446561

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)


Sponsor

Myogen, Inc.

Enrollment

800 participants

Start Date

Jan 1, 2007

Study Type

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

Sex: Both males and femalesMin Age: 35 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests darusentan, a new blood pressure medication, in people whose high blood pressure is not controlled despite taking three or more drugs including a diuretic (resistant hypertension). Adults ages 35 to 80 with resistant hypertension take darusentan or a comparison drug to see which lowers blood pressure more.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

United States of America

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