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

About the trial

Sponsor

Organon and Co

Tested

ezetimibe/simvastatin (drug), simvastatin (drug), Placebo for simvastatin 40 mg (drug), Placebo for ezetimibe 10 mg/simvastatin 40 mg combination (drug)

Dates

Started 2005-10-17; completion 2014-09-18

Results posted

Yes

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 inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit …

From ClinicalTrials.gov, last updated 2024-06-18. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Philips North America LLC reported $1,430 in research payments for this study in 2025 (2 payments).

Products named: Flexcare Platinum

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.