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
1 other identifier
interventional
1,800
0 countries
N/A
Brief Summary
To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2002
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 7, 2003
CompletedFirst Posted
Study publicly available on registry
January 9, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedJanuary 10, 2014
January 1, 2014
3.3 years
January 7, 2003
January 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from randomization to all-cause mortality or cardiovascular hospitalization
Baseline to Month 6
Secondary Outcomes (2)
Change in Patient Global Assessment score
Baseline to Month 6
Change in Six-Minute Walk Test
Baseline to Month 6
Study Arms (2)
Enoximone
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2003
First Posted
January 9, 2003
Study Start
February 1, 2002
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
January 10, 2014
Record last verified: 2014-01