A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

Trial Profile

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

Completed
Phase of Trial: Phase III

Latest Information Update: 16 May 2017

At a glance

  • Drugs Levosimendan (Primary)
  • Indications Low cardiac output
  • Focus Registrational; Therapeutic Use
  • Acronyms LEVO-CTS
  • Sponsors Tenax Therapeutics
  • Most Recent Events

    • 16 May 2017 Results of a subgroup analysis published in the Tenax Therapeutics Media Release
    • 16 May 2017 According to a Tenax Therapeutics media release, the company has met with the FDA on May 10, 2017 to review additional data analyses of the sub group of 66% of patients from this trial. As a follow-up to the pre-NDA meeting, the FDA requested submission of additional information from published cross study analyses.
    • 21 Mar 2017 According to a Tenax Therapeutics media release, based on the existing data in ADHF, along with the positive data generated in the secondary endpoints in this trial company is planning a pre-NDA meeting with FDA to discuss a New Drug Application (NDA) in the U.S.
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