RecruitingPhase 3ACTRN12606000292572

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)


Sponsor

Myogen, inc.

Enrollment

350 participants

Start Date

Sep 1, 2006

Study Type

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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called darusentan to see if it can lower blood pressure in people whose high blood pressure cannot be controlled even with four or more blood pressure medications. This type of hard-to-treat high blood pressure is called resistant hypertension. Participants will be randomly assigned to take one of three doses of darusentan or a sugar pill (placebo) for 14 weeks to see which dose works best and is safe. You may be eligible if: - You are between 35 and 80 years old - You have high systolic (top number) blood pressure that stays high despite taking four or more blood pressure medications at full doses, including a water pill (diuretic) - If you have diabetes or kidney disease, your systolic blood pressure is 130 mmHg or higher - If you do not have those conditions, your systolic blood pressure is 140 mmHg or higher - Women must be post-menopausal (at least 2 years) or have had surgery that prevents pregnancy You may NOT be eligible if: - Your systolic blood pressure is 180 mmHg or higher, or diastolic (bottom number) is 110 mmHg or higher - You have had a heart attack, unstable chest pain, or stroke in the past 6 months - You have certain heart rhythm problems or a pacemaker - You have Type 1 diabetes - You are on dialysis or have had a kidney transplant - You have been diagnosed with cancer in the past 3 years - You have untreated or poorly managed sleep apnea - You work night shifts - You are currently in another clinical trial Talk to your doctor about whether this trial might be right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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)

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)

United States of America

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12606000292572


Related Trials