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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00389779 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: darusentan (LU 135252), guanfacine, and placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects With Resistant Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312) |
Estimated Enrollment: | 770 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
50, 100 or 300 mg
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Drug: darusentan (LU 135252), guanfacine, and placebo
1 capsule QD, PO
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2: Active Comparator
1 mg
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Drug: darusentan (LU 135252), guanfacine, and placebo
1 capsule QD, PO
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3: Placebo Comparator |
Drug: darusentan (LU 135252), guanfacine, and placebo
1 capsule QD, PO
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Ages Eligible for Study: | 35 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
SELECTED INCLUSION CRITERIA:
SELECTED EXCLUSION CRITERIA:
Contact: Kathleen DeHaven | 720-887-8500 | kathleen.dehaven@gilead.com |
Responsible Party: | Gilead Sciences, Inc. ( Kathleen DeHaven, Associate Director, Clinical Trial Management ) |
Study ID Numbers: | Protocol DAR-312 |
Study First Received: | October 17, 2006 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00389779 |
Health Authority: | United States: Food and Drug Administration |
Guanfacine Vascular Diseases Hypertension |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions |