pssst back... with your statement you keep calling the FDA , TENX CEO and lead investigator John H. Alexander from Duke (DRCI) a liar and implement that they are misguiding and frauding investors and tax payers money!
if there would be products which help, there would be no LCOS anymore, common sense !
no market for LCOS? talk to the US-families and friends of the victims who suffered and died of LCOS... your comments are not only ignorant they are unethical and misleading....
You suggest that the FDA is wasting time and tax payers money to approve a phase 3-fast track study, you say that the FDA is on purpose misguiding? you seriously believe the FDA does not see the need of such an indication being treated? maybe you should discuss your opinion with the FDA...
LEVO-CTS Phase 3 trial designed to assess the benefits of levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome (LCOS).
“We are pleased to begin this important Phase 3 study, which has been designed in consultation with leading cardiovascular experts and investigators to provide a clear answer on the potential of levosimendan to prevent complications after high-risk cardiac surgery,” said John Kelley, CEO of Tenax Therapeutics. “We look forward to working with our colleagues at Duke Clinical Research Institute and the other cardiac surgery centers and hospitals involved in the trial, as we continue to activate many additional clinical sites in the months ahead.”
LEVO-CTS is a multi-center, double blind, randomized, placebo-controlled clinical trial that is testing the hypothesis that levosimendan reduces morbidity and mortality in cardiac surgery patients at risk for developing (LCOS). The U.S. Food and Drug Administration (FDA) has already granted Fast Track status for levosimendan in this LCOS indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA) with guidance that this single successful trial will be sufficient to support approval.
“The LEVO-CTS trial design will test levosimendan in the prevention of LCOS in high-risk patients undergoing cardiac surgery – an area of high unmet medical need and one where several smaller published clinical trials have suggested potential benefit,”[color=red][/color] said lead investigator John H. Alexander, M.D., MHS, Director of Cardiovascular Research, Duke Clinical Research Institute (DCRI). “We are pleased to be getting started with enrollment and are projected to have results in early 2016.”
The LEVO-CTS trial is being led by DCRI and will take place at approximately 50 major cardiac surgery centers in North America. It is seeking to enroll 760 patients undergoing coronary artery bypass graft surgery or mitral valve surgery that are at risk for developing LCOS.
The trial is event-driven, and includes a review of the event rate after the first 200 patients have been randomized in the trial. Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.
