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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00353574 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: darusentan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study 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-E) |
Estimated Enrollment: | 300 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
50 mg
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Drug: darusentan
3 tablets QD, PO
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2: Experimental
100 mg
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Drug: darusentan
3 tablets QD, PO
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3: Experimental
300 mg
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Drug: darusentan
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, Associate Director, Clinical Trial Management ) |
Study ID Numbers: | DAR-311-E |
Study First Received: | July 17, 2006 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00353574 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Resistant Hypertension |
Diuretics Vascular Diseases Cardiovascular Agents Antihypertensive Agents Hypertension |
Therapeutic Uses Vascular Diseases Cardiovascular Diseases Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Hypertension |