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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00051285
First received: January 7, 2003
Last updated: January 8, 2014
Last verified: January 2014
  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
Drug: Enoximone placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Time from randomization to all-cause mortality or cardiovascular hospitalization [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Patient Global Assessment score [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Improvement in quality of life assessed by the Patient Global Assessment patient-reported outcomes tool

  • Change in Six-Minute Walk Test [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Improvement in quality of life assessed by the Six-Minute Walk Test, a measure of submaximal exercise tolerance


Estimated Enrollment: 1800
Study Start Date: February 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enoximone Drug: Enoximone
Participants receive oral enoximone
Placebo Comparator: Placebo Drug: Enoximone placebo
Participants receive placebo to match enoximone

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00051285     History of Changes
Other Study ID Numbers: ESSENTIAL: My-021 and My-026
Study First Received: January 7, 2003
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Enoximone
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014