Tenax Therapeutics Enrolls First Patients In Phase 3 Trial For Levosimendan

(RTTNews) - Tenax Therapeutics, Inc. (TENX) Monday said it enrolled the first patients for its final-stage trial to study the effects of levosimendan in patients who are at risk of developing a certain clinical condition post cardiac surgery.

The Phase 3 trial will test whether levosimendan reduces morbidity and mortality in cardiac surgery patients at risk for developing low cardiac output syndrome, a common postoperative complication after cardiac surgery.

FDA has already granted Fast Track status for levosimendan in this LCOS indication, the company said, and has agreed that this single trial, if successful, will be sufficient to support approval.

The trial, named LEVO-CTS, is a multi-center, double blind, randomized, placebo-controlled study. Tenax said it expects to have the results in early 2016.