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The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure

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NCT00082589

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Castro Valley, California, 94546 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Congestive Heart Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Current symptoms consistent with mild to moderate heart failure (NYHA functional class
II and III)

- LVEF (left ventricular ejection fraction) of screening

- Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor
blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3
months duration and at dose that has not been adjusted within the previous 4 weeks

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Current decompensated heart failure or heart failure hospitalization or severe heart
failure (NYHA functional class IV) within 6 months of screening

- Use of eplerenone or spironolactone within 30 days of randomization or for more than 7
days within the previous 6 months

NCT00082589
Pfizer
Completed
The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure

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The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
A Randomized, Double-Blind, Multi-Center,Study Evaluating the Effects of Eplerenone Versus Placebo on Ventricular Remodeling in Patient's With Left Ventricular Systolic Dysfunction (EF Less Than or Equal to 35%) and Mild to Moderate Heart Failure
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Heart Failure, Congestive
Drug: Eplerenone
Not Provided
Udelson JE, Feldman AM, Greenberg B, Pitt B, Mukherjee R, Solomon HA, Konstam MA. Randomized, double-blind, multicenter, placebo-controlled study evaluating the effect of aldosterone antagonism with eplerenone on ventricular remodeling in patients with mild-to-moderate heart failure and left ventricular systolic dysfunction. Circ Heart Fail. 2010 May;3(3):347-53. doi: 10.1161/CIRCHEARTFAILURE.109.906909. Epub 2010 Mar 18.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
March 2006
Not Provided

Inclusion Criteria:

  • Current symptoms consistent with mild to moderate heart failure (NYHA functional class II and III)
  • LVEF (left ventricular ejection fraction) of <35% by equilibrium-gated RVG at screening
  • Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3 months duration and at dose that has not been adjusted within the previous 4 weeks

Exclusion Criteria:

  • Current decompensated heart failure or heart failure hospitalization or severe heart failure (NYHA functional class IV) within 6 months of screening
  • Use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00082589
A6141078
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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