ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
Recruitment status was Active, not recruiting
To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 cv hosp (pooled data for My-021 and My-026);change in PGA and submax exercise six months post-randomization (separate analyses within My-021 and My-026)
|Study Start Date:||February 2002|
|Estimated Study Completion Date:||December 2004|
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.