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NCT00082589 Clinical Trial

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

Heart Failure, Congestive Clinical Trial

— REMODEL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00082589
Other study ID # A6141078
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2004
Est. completion date March 2006

Study information
Verified date December 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Eplerenone

Locations
Country Name City State
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Auburn Maine
United States Pfizer Investigational Site Augusta Georgia
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Bloomington Illinois
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Castro Valley California
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Covington Georgia
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Fort Lauderdale Florida
United States Pfizer Investigational Site Galax Virginia
United States Pfizer Investigational Site Germantown Tennessee
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Lebanon New Hampshire
United States Pfizer Investigational Site Lexington Nebraska
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Lorain Ohio
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Manhasset New York
United States Pfizer Investigational Site McCook Nebraska
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Mount Airy North Carolina
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Haven Connecticut
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Normal Illinois
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Pawtucket Rhode Island
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Roanoke Virginia
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Sandusky Ohio
United States Pfizer Investigational Site Santa Rosa California
United States Pfizer Investigational Site Sayre Pennsylvania
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site West Islip New York
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)
See also
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Completed NCT02772068 - Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a Early Phase 1
Completed NCT02925546 - A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets Phase 1
Completed NCT01074307 - A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea Phase 4

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