DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertension

In brief

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, 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 three or more antihypertensive drugs, including a diuretic.

Key facts

Study ID

NCT00330369

Run by

Gilead Sciences

People needed

352

Starts

2006-06-01

Expected to finish

2009-01-01

Last updated by the study team

2014-03-18

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are competent to provide written consent
• Aged 35 to 80 years
• Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg
• All other subjects must have a mean systolic blood pressure ≥140 mmHg
• Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
• Female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)

You may not qualify if…

• Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
• Serum ALT or AST >2 x the upper limit of the normal range (ULN)
• Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
• Implanted pacemakers or implanted cardioverter defibrillator (ICD)
• Symptomatic congestive heart failure requiring treatment
• Hemodynamically significant valvular heart disease
• Type I diabetes mellitus
• Hemodialysis or peritoneal dialysis; or history of renal transplant
• Diagnosis or recurrence of malignancy within the past 3 years
• Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
• Subjects who perform alternating shift or night work
• Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening

Where it is running

• Comprehensive Heart Failure Center — Mobile, Alabama, United States
• Canyon Clinical Research — Tucson, Arizona, United States
• Chrishard Medical Group — Inglewood, California, United States
• VA Medical Center - WLA — Los Angeles, California, United States
• Sacramento Heart and Vascular — Sacramento, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Complete Renal Care — Denver, Colorado, United States
• Connecticut Clinical Research, LLC — Bridgeport, Connecticut, United States
• MedStar Diabetes Institute at Washington Hospital Center — Washington D.C., District of Columbia, United States
• Deerfield Beach Cardiology Associates — Deerfield Beach, Florida, United States
• White-Wilson Medical Center — Fort Walton Beach, Florida, United States
• AMK Research — Gainsville, Florida, United States
• A.G.A. Clinical Trials — Hialeah, Florida, United States
• Jacksonville Center for Clinical — Jacksonville, Florida, United States
• Ricardo A. Bedoya, Cardiology — Jupiter, Florida, United States
• International Research Association — Miami, Florida, United States
• Cardiovascular Center of Sarasota — Sarasota, Florida, United States
• Tampa Bay Nephrology — Tampa, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Global Research Partners — Calhoun, Georgia, United States
• Kula Research — Honolulu, Hawaii, United States
• Chicago Heart & Vein Clinic — Elk Grove Village, Illinois, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• Clinical Investigation Specialists, Inc. — Gurnee, Illinois, United States
• UAB Hypertension Program — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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