ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
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|ClinicalTrials.gov Identifier: NCT00051285|
Recruitment Status : Terminated
First Posted : January 9, 2003
Last Update Posted : January 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Drug: Enoximone Drug: Enoximone placebo||Phase 3|
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 1:1 ratio to receive either enoximone or placebo at the Randomization Visit. The initial dose of study drug will be 25 mg t.i.d.(3xday) and will be administered immediately after randomization. Subjects who tolerate this initial dose will be continued on 25 mg t.i.d. for at least two weeks. After two weeks, eligible subjects will be titrated to 50 mg t.i.d. for the duration of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1800 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||February 2002|
|Primary Completion Date :||June 2005|
|Study Completion Date :||June 2005|
Participants receive oral enoximone
|Placebo Comparator: Placebo||
Drug: Enoximone placebo
Participants receive placebo to match enoximone
- Time from randomization to all-cause mortality or cardiovascular hospitalization [ Time Frame: Baseline to Month 6 ]
- Change in Patient Global Assessment score [ Time Frame: Baseline to Month 6 ]Improvement in quality of life assessed by the Patient Global Assessment patient-reported outcomes tool
- Change in Six-Minute Walk Test [ Time Frame: Baseline to Month 6 ]Improvement in quality of life assessed by the Six-Minute Walk Test, a measure of submaximal exercise tolerance