Viewing Study NCT00353574



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Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00353574
Status: TERMINATED
Last Update Posted: 2014-03-18
First Post: 2006-07-17

Brief Title: DORADO-EX Long-Term Safety Extension Study to the Phase 3 DORADO Study Protocol DAR-311 of Darusentan in Resistant Hypertension
Sponsor: Gilead Sciences
Organization: Gilead Sciences

Study Overview

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
Status: TERMINATED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Study DAR-312 did not meet primary co-endpoints
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Darusentan
Brief Summary: This is a research study of a new experimental drug called darusentan Darusentan is not currently approved by the United States US Food and Drug Administration FDA for use in the US 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
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