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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00082589
First received: May 12, 2004
Last updated: May 22, 2008
Last verified: April 2007
  Purpose

The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure


Condition Intervention Phase
Heart Failure, Congestive
Drug: Eplerenone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)

Estimated Enrollment: 250
Study Start Date: April 2004
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082589

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Castro Valley, California, United States, 94546
Pfizer Investigational Site
San Diego, California, United States, 92103-8411
Pfizer Investigational Site
Santa Rosa, California, United States, 95403
Pfizer Investigational Site
Walnut Creek, California, United States, 94598-3084
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80262
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
United States, Florida
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33308
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Jacksonville, Florida, United States, 32209
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30309-1721
Pfizer Investigational Site
Augusta, Georgia, United States, 30901
Pfizer Investigational Site
Covington, Georgia, United States, 30014
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83704-0107
United States, Illinois
Pfizer Investigational Site
Bloomington, Illinois, United States, 61701
Pfizer Investigational Site
Normal, Illinois, United States, 61761
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46260
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maine
Pfizer Investigational Site
Auburn, Maine, United States, 04210
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48105
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55415
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55422
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63104
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110-0250
Pfizer Investigational Site
St. Louis, Missouri, United States, 63117
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Pfizer Investigational Site
Lexington, Nebraska, United States, 68850
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68516
Pfizer Investigational Site
McCook, Nebraska, United States, 69001
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12205
Pfizer Investigational Site
Manhasset, New York, United States, 11030
Pfizer Investigational Site
New York, New York, United States, 10032
Pfizer Investigational Site
West Islip, New York, United States, 11795
United States, North Carolina
Pfizer Investigational Site
Mount Airy, North Carolina, United States, 27030
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27109
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Lorain, Ohio, United States, 44053
Pfizer Investigational Site
Sandusky, Ohio, United States, 44870-3390
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Pfizer Investigational Site
Sayre, Pennsylvania, United States, 18840
United States, Rhode Island
Pfizer Investigational Site
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29401
United States, Tennessee
Pfizer Investigational Site
Germantown, Tennessee, United States, 38138
Pfizer Investigational Site
Nashville, Tennessee, United States, 37212
United States, Texas
Pfizer Investigational Site
Beaumont, Texas, United States, 77630
Pfizer Investigational Site
Beaumont, Texas, United States, 77702
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Pfizer Investigational Site
Galax, Virginia, United States, 24333
Pfizer Investigational Site
Roanoke, Virginia, United States, 24014
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00082589     History of Changes
Other Study ID Numbers: A6141078
Study First Received: May 12, 2004
Last Updated: May 22, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014