Heart Failure, Congestive Clinical Trial
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
To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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