A Phase 3 interventional study of Darusentan in Hypertension, sponsored by Gilead Sciences. Terminated at 75 sites in 8 countries. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-03-18.
Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 282 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Darusentan 50 mg administered orally once daily
Drug: Darusentan
Darusentan 100 mg administered orally once daily
Drug: Darusentan
Darusentan 300 mg administered orally once daily
Drug: Darusentan
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
This study is terminated, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Gilead Sciences