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
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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COMPLETED
PHASE4
250 participants
INTERVENTIONAL
2004-04-30
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Eplerenone
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months
21 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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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
Countries
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6141078
Identifier Type: -
Identifier Source: org_study_id