NCT00414609

Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 820 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Aliskiren	Aliskiren was available in 75 mg tablet, 150 mg tablet
DRUG	placebo	Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-09-01
• Completion: 2011-07-01
• First posted: 2006-12-21
• Last updated: 2012-07-13
• Results posted: 2011-07-13

Locations

23 sites across 23 countries: United States, Argentina, Belgium, Canada, Colombia, Czechia, Denmark, Germany, Hungary, India, Israel, Italy, Netherlands, Norway, Poland, Russia, Slovakia, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, Venezuela