Viewing Study NCT00389779



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00389779
Status: COMPLETED
Last Update Posted: 2014-03-18
First Post: 2006-10-17

Brief Title: DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
Sponsor: Gilead Sciences
Organization: Gilead Sciences

Study Overview

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
Status: COMPLETED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Darusentan
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None