Simdax levosimendan: Phase III ongoing

An independent DSMB recommended continuation of the double-blind, placebo-controlled, North American Phase III LEVO-CTS trial evaluating IV levosimendan based on safety data from the first 254 patients enrolled. LEVO-CTS, which has enrolled 388 patients, is seeking 760 patients undergoing coronary artery bypass graft (CABG) surgery or mitral valve surgery who are at risk for developing LCOS. Patients will receive 0.2 ug/kg/minute levosimendan for 1 hour, followed by a 0.1 ug/kg/minute dose for 23 hours. The company has an SPA from FDA for the trial. ...