Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051285
Status:
TERMINATED
Last Update Posted:
2014-01-10
First Post:
2003-01-07
Brief Title:
ESSENTIAL-The Studies of Oral Enoximone Therapy in Advanced Heart Failure
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
ESSENTIAL Protocol No My-021 and Protocol No My-026 Each Titled A Phase III Randomized Double-Blind Multicenter Parallel Group Placebo-Controlled Study of Oral Enoximone vs Placebo in Advanced Chronic Heart Failure Subjects
Status:
TERMINATED
Status Verified Date:
2014-01
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:
None
Brief Summary:
To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure
Detailed Description:
The study is a randomized double-blind multicenter parallel group placebo-controlled trial of oral enoximone in approximately 700 subjects with advanced chronic heart failure of either ischemic or nonischemic etiology receiving optimal conventional heart failure therapy
Eligible subjects will be randomized in a 11 ratio to receive either enoximone or placebo at the Randomization Visit The initial dose of study drug will be 25 mg tid3xday and will be administered immediately after randomization Subjects who tolerate this initial dose will be continued on 25 mg tid for at least two weeks After two weeks eligible subjects will be titrated to 50 mg tid for the duration of the study
Eligible subjects will be randomized in a 11 ratio to receive either enoximone or placebo at the Randomization Visit The initial dose of study drug will be 25 mg tid3xday and will be administered immediately after randomization Subjects who tolerate this initial dose will be continued on 25 mg tid for at least two weeks After two weeks eligible subjects will be titrated to 50 mg tid for the duration of the study
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