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

NCT ID: NCT00082589

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Eplerenone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Castro Valley, California, United States

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San Diego, California, United States

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Santa Rosa, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Covington, Georgia, United States

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Boise, Idaho, United States

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Bloomington, Illinois, United States

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Normal, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Auburn, Maine, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Lexington, Nebraska, United States

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Lincoln, Nebraska, United States

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McCook, Nebraska, United States

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Lebanon, New Hampshire, United States

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Albany, New York, United States

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Manhasset, New York, United States

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New York, New York, United States

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West Islip, New York, United States

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Mount Airy, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Lorain, Ohio, United States

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Sandusky, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Charleston, South Carolina, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Beaumont, Texas, United States

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Beaumont, Texas, United States

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Houston, Texas, United States

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Galax, Virginia, United States

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Roanoke, Virginia, United States

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Madison, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20299607 (View on PubMed)

Related Links

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Other Identifiers

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A6141078

Identifier Type: -

Identifier Source: org_study_id