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

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Study Location
Pfizer Investigational Site
Castro Valley, California, 94546, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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 <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
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

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Congestive Heart FailureThe Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
NCT00082589
  1. Castro Valley, California
  2. San Diego, California
  3. Santa Rosa, California
  4. Walnut Creek, California
  5. Denver, Colorado
  6. New Haven, Connecticut
  7. Fort Lauderdale, Florida
  8. Jacksonville, Florida
  9. Jacksonville, Florida
  10. Atlanta, Georgia
  11. Augusta, Georgia
  12. Covington, Georgia
  13. Boise, Idaho
  14. Bloomington, Illinois
  15. Normal, Illinois
  16. Indianapolis, Indiana
  17. Indianapolis, Indiana
  18. Auburn, Maine
  19. Ann Arbor, Michigan
  20. Detroit, Michigan
  21. Minneapolis, Minnesota
  22. Minneapolis, Minnesota
  23. St. Louis, Missouri
  24. St. Louis, Missouri
  25. St. Louis, Missouri
  26. St. Louis, Missouri
  27. Lexington, Nebraska
  28. Lincoln, Nebraska
  29. McCook, Nebraska
  30. Lebanon, New Hampshire
  31. Albany, New York
  32. Manhasset, New York
  33. New York, New York
  34. West Islip, New York
  35. Mount Airy, North Carolina
  36. Winston-Salem, North Carolina
  37. Cincinnati, Ohio
  38. Lorain, Ohio
  39. Sandusky, Ohio
  40. Oklahoma City, Oklahoma
  41. Philadelphia, Pennsylvania
  42. Philadelphia, Pennsylvania
  43. Sayre, Pennsylvania
  44. Pawtucket, Rhode Island
  45. Charleston, South Carolina
  46. Germantown, Tennessee
  47. Nashville, Tennessee
  48. Beaumont, Texas
  49. Beaumont, Texas
  50. Houston, Texas
  51. Galax, Virginia
  52. Roanoke, Virginia
  53. Madison, Wisconsin
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Heart Failure, Congestive
Intervention  ICMJE Drug: Eplerenone
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 1, 2005)		250
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00082589
Other Study ID Numbers  ICMJE A6141078
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP