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

Completed · Phase 4

Conditions studied: Heart Failure, Congestive

In brief

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

Key facts

Study ID

NCT00082589

Run by

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

People needed

250

Starts

2004-04-01

Expected to finish

2006-03-01

Last updated by the study team

2020-12-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Pfizer Investigational Site — Augusta, Georgia, United States
• Pfizer Investigational Site — Covington, Georgia, United States
• Pfizer Investigational Site — Boise, Idaho, United States
• Pfizer Investigational Site — Bloomington, Illinois, United States
• Pfizer Investigational Site — Normal, Illinois, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Auburn, Maine, United States
• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Castro Valley, California, United States

Full record on ClinicalTrials.gov

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