Simdax levosimendan: Phase III started

Tenax began the double-blind, placebo-controlled, North American Phase III LEVO-CTS trial to evaluate IV Simdax in 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 Simdax for 1 hour, followed by a 0.1 Ug/kg/minute dose for 23 hours.

The company has an SPA for the trial and said it received guidance from FDA that a single "successful" trial will be sufficient to support approval for the indication. Simdax also has Fast Track designation in the U.S. for reducing morbidity and mortality in cardiac surgery patients at risk for developing LCOS. The company expects an event rate interim analysis following enrollment of 200 patients by 1H15; 2 interim analyses in 2H15 for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded; and full data in 1Q16. ...