At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,012 enrolled
Drug / intervention
Eplerenone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Aug 6, 2010·Updated Dec 22, 2020
In Brief
A Phase 4 clinical trial evaluating Eplerenone and Placebo for Myocardial Infarction. Completed, enrolled 1,012 participants across 75 sites in 11 countries.
Detailed Summary
Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyocardial Infarction
CountriesCanada, Czechia, France, Germany, Greece, Hungary, Netherlands, Poland, Slovakia, Spain, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartSep 2010
Primary CompletionOct 2012
TodayJul 2026
First PostedAug 6, 2010
Enrollment StartSep 1, 2010
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.9 years ago
Interventions
Eplerenonedrug
Maximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data.
Placebodrug
Matching placebo tablets