This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in 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 evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
661
Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
Guanfacine 1 mg capsules administered orally once daily
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Time frame: Baseline to Week 14
Percentage of subjects who reach systolic blood pressure goal
Time frame: Week 14
Change from baseline in estimated glomerular filtration rate (eGFR)
Time frame: Baseline to Week 14
Change from baseline in trough sitting systolic and diastolic blood pressures
Time frame: Baseline to Week 14
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