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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Eplerenone; Spironolactone

Criteria

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