Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT trial has completed its planned review of study data and recommended that the study continue.
The study design calls for the collection of 5,250 clinical endpoints. Merck remains blinded to the actual results of this analysis and to other IMPROVE-IT safety and efficacy data.
IMPROVE-IT is an 18,141 patient event-driven trial, and based on the targeted number of clinical endpoints and the rate at which events are being reported, the trial is projected to conclude in September 2014. The IMPROVE-IT Executive Committee and Merck will continue to monitor the progress of the study, and Merck will update the study timeline if appropriate. No additional interim analyses are planned.
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