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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00330369 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: darusentan (LU 135252) and placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | DORADO - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311) |
Estimated Enrollment: | 352 |
Study Start Date: | June 2006 |
Study Completion Date: | January 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: darusentan (LU 135252) and placebo
3 tablets QD, PO
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2: Experimental
50 mg
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Drug: darusentan (LU 135252) and placebo
3 tablets QD, PO
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3: Experimental
100 mg
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Drug: darusentan (LU 135252) and placebo
3 tablets QD, PO
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4: Experimental
300 mg
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Drug: darusentan (LU 135252) and placebo
3 tablets QD, PO
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Ages Eligible for Study: | 35 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Gilead Sciences, Inc ( Kathleen DeHaven ) |
Study ID Numbers: | DAR-311 |
Study First Received: | May 24, 2006 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00330369 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diuretics Vascular Diseases Antihypertensive Agents Hypertension |
Vascular Diseases Cardiovascular Diseases Hypertension |