Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077948
Status:
TERMINATED
Last Update Posted:
2014-01-10
First Post:
2004-02-13
Brief Title:
Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase III Randomized Double-Blind Double Placebo-Controlled Multicenter Three Parallel Group Study of Enoximone Plus Extended-Release Metoprolol Succinate in Advanced CHF Subjects Previously Intolerant to Beta-Blocker Treatment
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:
Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure CHF Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects such as low blood pressure andor low heart rate severe tiredness dizziness or shortness of breath In other words they have difficulty tolerating beta-blocker medications The purpose of this study is to determine if enoximone can improve a patients ability to tolerate a beta-blocker medication
Detailed Description:
Over the last decade it has become evident that certain beta-blocking agents beta-blockers exert a favorable effect on the natural history of mild to moderate chronic heart failure CHF including reducing mortality and hospitalization rate However as heart failure becomes more severe beta-blockers become difficult to administer because of myocardial depression leading to hemodynamic intolerance A recent clinical study demonstrated that subjects who could not tolerate the beta-blocker metoprolol experienced improved tolerability when low-dose oral enoximone was administered prior to the introduction of metoprolol and during ongoing treatment This study will investigate the hypotheses that by stabilizing subjects on enoximone first advanced CHF subjects who are intolerant of beta-blockade will be able to 1 tolerate the effects of beta-blocker therapy and 2 have clinical benefit that is due to the combination of both enoximone and extended-release metoprolol succinate ER metoprolol Support for these hypotheses will be sought by demonstrating that as compared to placebo low-dose oral enoximone plus ER metoprolol will increase left ventricular ejection fraction LVEF improve symptoms of heart failure and improve submaximal exercise tolerance in subjects with CHF
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