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ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
This study is ongoing, but not recruiting participants.
Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00051285
  Purpose

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

MedlinePlus related topics: Heart Failure
Drug Information available for: Enoximone
U.S. FDA Resources
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • Multiple

Estimated Enrollment: 1800
Study Start Date: February 2002
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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

Keywords provided by Gilead Sciences:
CHF
heart
failure
congestive
enoximone
phosphodiesterase
inhibitor

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Enoximone

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009