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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
352
Darusentan administered orally once daily
Placebo to match darusentan administered orally once daily
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry
Time frame: Baseline to Week 14
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Time frame: Baseline to Week 14
Percentage of subjects to reach systolic blood pressure goal
Time frame: Week 14
Change from baseline in estimated glomerular filtration rate (eGFR)
Time frame: Baseline to Week 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UAB Hypertension Program
Birmingham, Alabama, United States
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
...and 105 more locations