Status:
COMPLETED
The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00082589
Start Date
April 1 2004
End Date
March 1 2006
Last Update
December 22 2020
Active Locations (53)
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1
Pfizer Investigational Site
Castro Valley, California, United States, 94546
2
Pfizer Investigational Site
San Diego, California, United States, 92103-8411
3
Pfizer Investigational Site
Santa Rosa, California, United States, 95403
4
Pfizer Investigational Site
Walnut Creek, California, United States, 94598-3084