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
Inclusion Criteria1
- Subjects who are competent to provide written consent; 2) Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg; 3) All other subjects must have an average sitting systolic blood pressure greater than or equal to 140 mmHg; 4) Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic; 5) Female subjects must be of non-childbearing potential (post-menopausal for at least 2 years or surgically sterile).
Exclusion Criteria1
- Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively; 2) Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist; 3) Left ventricular dysfunction; 4) Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) greater than 2 times the Upper Limit of Normal; 5) Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachycardia, recurrent ventricular tachycardia, or symptomatic bradycardia; 6) Implanted pacemakers or cardioverter defibrillator; 7) Symptomatic CHF requiring treatment; 8) Hemodynamically significant valvular heart disease; 9) Hemodialysis or peritoneal dialysis, or history of renal transplant; 10) Type I diabetes mellitus; 11) Diagnosis or recurrence of malignancy within the past 3 years; 12) Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than 90%, treated or untreated; 13) Subjects who perform alternating shift or night work; 14) Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.
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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.
Locations(1)
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ACTRN12606000446561