NCT00051285

ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (planned)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.

Detailed description

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.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DRUG	Enoximone	Participants receive oral enoximone
DRUG	Enoximone placebo	Participants receive placebo to match enoximone

Timeline

• Start date: 2002-02-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2003-01-09
• Last updated: 2014-01-10