CLINICAL TRIALS PROFILE FOR DARUSENTAN

Clinical Trials for Darusentan

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00330369 ↗	DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension	Completed	Gilead Sciences	Phase 3	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.
NCT00353574 ↗	DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension	Terminated	Gilead Sciences	Phase 3	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.
NCT00364026 ↗	A Clinical Study to Evaluate the Effects of Darusentan on Safety and Efficacy in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Blood Pressure Lowering Drugs	Completed	Gilead Sciences	Phase 2	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 blood pressure lowering drugs, including a diuretic.
NCT00389675 ↗	DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension	Terminated	Gilead Sciences	Phase 3	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.
NCT00389779 ↗	DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension	Completed	Gilead Sciences	Phase 3	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.
NCT00738049 ↗	Darusentan Effect on PET Uptake Heterogeneity	Completed	Gilead Sciences	Phase 2	The primary objective of this study is to test the hypothesis that myocardial perfusion heterogeneity, quantified by Markovian Homogeneity analysis of cardiac PET perfusion images, will improve in a quantitative manner after treatment with selective ETA receptor antagonist darusentan 100 mg per day for 2 weeks compared to baseline and post-treatment PET scans in clinically stable subjects with coronary atherosclerosis and/or risk factors.

Clinical Trial Conditions for Darusentan

Condition Name

Condition Name
Intervention	Trials
Hypertension	5
Coronary Artery Disease	1
Endothelial Dysfunction	1

Condition MeSH

Condition MeSH
Intervention	Trials
Hypertension	5
Myocardial Ischemia	1
Coronary Disease	1
Coronary Artery Disease	1

Clinical Trial Locations for Darusentan

Trials by Country

Trials by Country
Location	Trials
United States	111
Argentina	5
Brazil	4
France	3
Denmark	3

Trials by US State

Trials by US State
Location	Trials
Texas	5
South Carolina	4
Rhode Island	4
Oregon	4
Oklahoma	4

Clinical Trial Progress for Darusentan

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	4
Terminated	2

Clinical Trial Sponsors for Darusentan

Sponsor Name

Sponsor Name
Sponsor	Trials
Gilead Sciences	6
K.Lance Gould	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	6
Other	1