Status:
COMPLETED
A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-mod...
Eligibility Criteria
Inclusion
- History (Hx) of chronic systolic heart failure of ischemic or non-ischemic etiology of at least 4 weeks duration; Currently, New York Heart Association (NYHA) functional Class II and on optimal dose, or maximally tolerated dose of standard heart failure medicines (advisable to include ACE-I/ARBs; beta-blockers) and diuretics if indicated for fluid overload. Should have participated in the double-blind phase of the EMPHASIS-HF trial
Exclusion
- Severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy; estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
2743 Patients enrolled
Trial Details
Trial ID
NCT00232180
Start Date
March 1 2006
End Date
January 1 2012
Last Update
December 22 2020
Active Locations (307)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85008
2
Pfizer Investigational Site
Loma Linda, California, United States, 92354
3
Pfizer Investigational Site
Merced, California, United States, 95340
4
Pfizer Investigational Site
Stockton, California, United States, 95204