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

Tracking Information
First Received Date ^ICMJE	January 7, 2003
Last Updated Date	January 17, 2007
Start Date ^ICMJE	February 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 9, 2005)	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)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00051285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 9, 2005)	Multiple
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
Official Title ^ICMJE	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
Brief Summary	To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Heart Failure, Congestive
Intervention ^ICMJE	Drug: enoximone
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1800
Completion Date	December 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00051285
Responsible Party
Study ID Numbers ^ICMJE	ESSENTIAL: My-021 and My-026
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Gilead Sciences
Verification Date	August 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP