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
This study has been completed.
First Posted: August 15, 2006
Last Update Posted: January 18, 2007
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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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase II Study to Evaluate the Effects of Darusentan on Safety and Efficacy in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-201)|
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Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Co-primary efficacy measures are changes in trough sitting systolic BP from baseline through Weeks 8 and 10.
Secondary Outcome Measures:
- Secondary efficacy measurements are change in trough sitting diastolic BP from baseline to study Week 10; change in mean 24-hour systolic BP, as measured by ABPM; and the percent of subjects who reached systolic BP goal after 10 weeks of treatment.
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||July 2005|
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