At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 820 enrolled
Drug / intervention
Aliskiren +1 moredrug
Likely dose
Aliskiren 75-150 mg orally once dailyAI-extracted
Key inclusion· 5
- ✓Age ≥18 years
- ✓Within 7-42 days of acute myocardial infarction with documented left ventricular systolic dysfunction
- ✓Stable doses (≥2 weeks) of beta-blocker, antiplatelet agent, statin, and ACEI or ARB (not both)
- ✓Qualifying echocardiogram at baseline visit
Key exclusion· 8
- ✕Requirement for dual ACEI and ARB combination therapy at any time during study
- ✕Severe refractory hypertension (mean SBP ≥180 mmHg and/or mean DBP ≥110 mmHg) at Visit 2
- ✕Cardiogenic shock or systolic BP <100 mmHg or diastolic <60 mmHg within 24 hours prior to Visit 1 or 2
- ✕eGFR <30 mL/min/1.73m² (MDRD formula) at baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 36-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Including a 2 Year Extension Study to Evaluate Efficacy and Safety of Aliskiren on the Prevention of Left Ventricular Remodeling in High Risk Post-acute Myocardial Infarction Patients When Added to Optimized Standard Therapy
In Brief
A Phase 3 clinical trial evaluating Aliskiren and placebo for Myocardial Infarction. Completed, enrolled 820 participants across 23 sites in 23 countries.
Detailed Summary
The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyocardial Infarction
CountriesArgentina, Belgium, Canada, Colombia, Czechia, Denmark, Germany, Hungary, India, Israel, Italy, Netherlands, Norway, Poland, Russia, Slovakia, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionSep 2009
Study CompletionJul 2011
TodayJul 2026
First PostedDec 21, 2006
Enrollment StartDec 1, 2006
Primary CompletionSep 1, 2009
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.5 years ago
Interventions
Aliskirendrug
Aliskiren was available in 75 mg tablet, 150 mg tablet
placebodrug
Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.