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

NCT00414609 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2012-07-13

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis US · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-09-30
Completion
2011-07-31

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00414609 on ClinicalTrials.gov