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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00051285
Recruitment Status : Terminated
First Posted : January 9, 2003
Last Update Posted : January 10, 2014
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: Enoximone Drug: Enoximone placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Enoximone Drug: Enoximone
Participants receive oral enoximone

Placebo Comparator: Placebo Drug: Enoximone placebo
Participants receive placebo to match enoximone

Primary Outcome Measures :
  1. Time from randomization to all-cause mortality or cardiovascular hospitalization [ Time Frame: Baseline to Month 6 ]

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

In order to be considered eligible subjects, the following entry criteria must be met:

  • At least 18 years of age
  • ischemic or nonischemic cardiomyopathy
  • NYHA Class III or IV
  • one hospitalization, or two outpatient visits, for the treatment of worsening heart failure within 12 months requiring the administration of I.V. heart failure therapy
  • LVEDD >3.2 cm/m2 or >=6.0 cm
  • LVEF of less than or equal to 30%
  • concomitant treatment with optimal conventional heart failure therapy

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:

  • Calcium antagonists other than amlodipine or felodipine
  • Flecainide, encainide, propafenone, dofetilide or disopyramide
  • Subjects receiving I.V. positive inotropic agents within seven days of the Screening Visit or Randomization Visit
  • Subjects receiving a human B-type natriuretic peptide, including nesiritide, within seven days of the Screening Visit or Randomization Visit
  • 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

    • Subjects with active hepatic (screening serum total bilirubin >= 3.0 mg/dl (>=51.3 umol/l), renal (screening serum creatinine >= 2.0 mg/dl (=178.8 umol/l)), hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease
    • Subjects with a serum potassium <4.0 mEq/L or >5.5 mEq/L (<4.0 mmol/l or >5.5 mmol/l) at Randomization Visit
    • Subjects with a magnesium level of <1.0 mEq/L (<0.5 mmol/l) at Randomization Visit (Visit 0)
    • Subjects with a serum digoxin of >1.2 ng/ml (>1.5 nmol/l) or a serum digitoxin of >20 ng/ml (>26.2 nmol/l) at the Randomization Visit are excluded. A target serum digoxin level of <=1.0 ng/ml (<=1.3 nmol/l) is recommended
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Responsible Party: Gilead Sciences Identifier: NCT00051285    
Other Study ID Numbers: ESSENTIAL: My-021 and My-026
First Posted: January 9, 2003    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs