IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)

Completed

Phase 3 Results

Summary of Purpose

This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 2 November 2015.

1 Oct 2005 13 Sep 2005 1 Sep 2014 1 Sep 2014 1 Nov 2015 28 Aug 2015
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Contacts

  • Amy McCagg Phone: 800-385-4444 Email: amccagg@partners.org

    cpcannon@partners.org