Medicure, a cardiovascular focused biopharmaceutical company, has reported the analysis of the data from its Phase 3 MEND-CABG II clinical trial showed that it did not meet the primary endpoint. The study results will be presented at the late-breaking clinical trial session during the 2008 ACC Scientific Sessions in Chicago.
The trial was designed to evaluate the effect of Medicure’s lead product MC-1, versus placebo, on the incidence of cardiovascular death or nonfatal MI up to and including 30 days following coronary artery bypass graft (CABG) surgery, according to the Winnipeg, Manitoba-based Medicure.
Based on the results, the company said it does not plan on submitting an application for MC-1 marketing approval to the FDA for the CABG indication at this time.
The Phase 3 MEND-CABG II trial was a double-blind, randomized, placebo-controlled clinical trial that enrolled over 3,000 patients undergoing CABG surgery at more than 130 cardiac surgical centers throughout North America and Europe.
Medicure conducted the MEND-CABG II study in conjunction with Duke Clinical Research Institute (DCRI) and Montreal Heart Institute (MHI). The principal investigators for the study are Robert Harrington, MD, director of the DCRI, and Michel Carrier, MD, director of cardiovascular surgery program at MHI.