This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
282
Darusentan capsules administered orally once daily
Change in trough sitting systolic and diastolic blood pressure
Time frame: Baseline to Week 14
Change in mean 24-hour systolic and diastolic ambulatory blood pressures.
Time frame: Baseline to Week 14
Percentage of subjects who reach systolic blood pressure goal
Time frame: Week 14
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline to Week 14
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