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The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT00082589•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (53)

Pfizer Investigational Site

Castro Valley, California, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Santa Rosa, California, United States

Pfizer Investigational Site

Walnut Creek, California, United States

Pfizer Investigational Site

Denver, Colorado, United States

Pfizer Investigational Site

New Haven, Connecticut, United States

Pfizer Investigational Site

Fort Lauderdale, Florida, United States

Pfizer Investigational Site

Jacksonville, Florida, United States

Pfizer Investigational Site

Jacksonville, Florida, United States

Pfizer Investigational Site

Atlanta, Georgia, United States

Key Dates

Start Date

April 1, 2004

Completion Date

March 1, 2006

Last Updated

December 22, 2020

Enrollment

250

Estimated participants

Conditions

Heart Failure, Congestive

Interventions

Eplerenone

DRUG

Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

NCT00733590

Heart Failure, CongestiveDeath, Sudden, Cardiac+2 more

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COMPLETEDNA

Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure

NCT00400985

Heart Failure, Congestive

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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