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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00051285 |
To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
Condition | Intervention | Phase |
---|---|---|
Heart Failure, Congestive |
Drug: enoximone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 1800 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
In order to be considered eligible subjects, the following entry criteria must be met:
Exclusion Criteria
Subjects who meet any one of the following criteria will be deemed ineligible for participation in the study:
Subjects on the following concomitant medications:
Subjects receiving oral or I.V. phosphodiesterase III inhibitors (PDEI III), including levosimendan and cilostazol, within seven days of the Screening Visit or Randomization Visit
Study ID Numbers: | ESSENTIAL: My-021 and My-026 |
Study First Received: | January 7, 2003 |
Last Updated: | January 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00051285 |
Health Authority: | United States: Food and Drug Administration |
CHF heart failure congestive |
enoximone phosphodiesterase inhibitor |
Heart Failure Heart Diseases Enoximone |
Vasodilator Agents Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents Protective Agents Pharmacologic Actions |