Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389675
Status:
TERMINATED
Last Update Posted:
2014-01-06
First Post:
2006-10-17
Brief Title:
DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study Protocol DAR-312 of Darusentan in Resistant Hypertension
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Double-Blind Active-Controlled Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects With Resistant Hypertension Despite Receiving Combination Therapy With Three or More Antihypertensive Drugs Including a Diuretic as Compared to Guanfacine Protocol DAR-312-E
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study DAR-312 did not meet its 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 double-blind active-controlled long-term study of a new experimental drug called darusentan Darusentan in 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 evaluate the long-term safety of darusentan optimized dose as compared to an active control administered orally
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