ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
|Heart Failure, Congestive||Drug: Enoximone Drug: Enoximone placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- 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
|Study Start Date:||February 2002|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Participants receive oral enoximone
|Placebo Comparator: Placebo||
Drug: Enoximone placebo
Participants receive placebo to match enoximone
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.
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