The executive committee of the ACCELERATE study recommended Eli Lilly and Company Pharmaceutics extend their Phase 3 trial investigating the efficacy of evacetrapib for cardiovascular disease by 6 months. Eli Lilly accepted this recommendation and the trial is now going to be conducted until July 2016.
The recommendation of the ACCELERATE academic executive committee was based on the review of recent trials evaluating the efficacy of other agents aimed at reducing major adverse cardiovascular events (MACE). Both parts considered that an extended treatment period would benefit the results of the ACCELERATE trial, a Phase 3 multicenter, randomized interventional study investigating the hypothesis that evacetrapib in combination with statins can diminish MACE events when compared evacetrapib alone in patients with high-risk atherosclerotic cardiovascular disease (ASCVD).
Participants in the experimental arm receive an Evacetrapib 130 mg tablet orally once a day for up to 4 years. Participants in the placebo arm receive a placebo tablet administered orally once daily for up to 4 years. Both groups also receive standard of care for high-risk vascular disease (HRVD).
The ACCELERATE trial began in October 2012 and now, according with a news release, the final data collection date for primary outcome measures is expected by July 2016. As part of the study extension decision, an interim analysis that was due to be conducted in Q1 2015 is now postponed to Q3 2015.
The study is being conducted in the following countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Lithuania, Mexico, The Netherlands, New Zealand, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey , The Ukraine, and The United Kingdom.