September 20, 2007 - Medicure Inc. today announced the completion of enrollment of 3,000 patients in its MEND-CABG II trial, as the company plans to develop the first cardioprotective therapy approved to reduce mortality and morbidity in the CABG patient population.
The Phase 3 trial for registration is evaluating the Company’s FDA Fast Tracked product MC-1’s safety and cardioprotective efficacy in patients undergoing coronary artery bypass graft (CABG) surgery.
The Phase 3 MEND-CABG II trial is a double-blind, randomized, placebo-controlled clinical trial that enrolled 3,000 patients undergoing CABG surgery at approximately 130 cardiac surgical centers throughout North America and Europe. Study patients were randomized to receive placebo or MC-1 250 mg prior to surgery and for 30 days post operatively (POD 30). The primary efficacy endpoint of MEND-CABG II is the incidence of cardiovascular death or non-fatal myocardial infarction up to and including POD 30. Study patients will be followed for 60 days after treatment (90 days post operatively) for additional safety and efficacy analysis. The study was initiated in November 2006 and is subject to a Special Protocol Assessment with the FDA.
For more information: www.medicure.com