DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00389779
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. 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), an active comparator, or placebo, administered orally. The treatment period for this trial is 14 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 849
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darusentan Darusentan Placebo Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily for 14 weeks Guanfacine Guanfacine Placebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks Guanfacine Darusentan Placebo Placebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks Darusentan Placebo Darusentan Placebo Placebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks Darusentan Darusentan Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily for 14 weeks
- Primary Outcome Measures
Name Time Method Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry Baseline to Week 14
- Secondary Outcome Measures
Name Time Method Percentage of subjects reaching systolic blood pressure goal after 14 weeks of treatment Week 14 Change from baseline in mean 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) Baseline to Week 14 Change from baseline in estimated glomerular filtration rate (eGFR) Baseline to Week 14
Trial Locations
- Locations (145)
Alabama Internal Medicine, PC
🇺🇸Birmingham, Alabama, United States
Greystone Medical Research, LLC
🇺🇸Birmingham, Alabama, United States
The Heart Center, PC
🇺🇸Huntsville, Alabama, United States
Mulberry Medical Associates, PC
🇺🇸Montgomery, Alabama, United States
Arizona Center for Clinical Research
🇺🇸Glendale, Arizona, United States
Cardiovascular Consultants, Ltd.
🇺🇸Glendale, Arizona, United States
Lovelace Scientific Resources, Inc
🇺🇸Phoenix, Arizona, United States
Cochise Clinical Research
🇺🇸Sierra Vista, Arizona, United States
Southwest Heart
🇺🇸Tucson, Arizona, United States
HealthFirst Physician of AR, PA dba Convenient Care Clinic
🇺🇸Hot Springs, Arkansas, United States
Scroll for more (135 remaining)Alabama Internal Medicine, PC🇺🇸Birmingham, Alabama, United States