US-based specialty pharmaceutical company Tenax has completed patient enrolment in its Phase III LEVO-CTS trial of Levosimendan to be used during cardiac surgery.

Discovered and developed by Orion Pharma, levosimendan is an intravenously administered calcium sensitiser for patients with acute decompensated congestive heart failure (CHF).

At therapeutic dosages, levosimendan improves myocardial contractility without increasing oxygen requirements and causes coronary and systemic vasodilation.

The double-blind, randomised, placebo-controlled LEVO-CTS study will test the use of levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome (LCOS) and associated morbidity and mortality.

"We are very pleased to reach this milestone after more than two years of hard work, and would like to thank all of the patients and investigators who have taken part in the trial."

The secondary endpoints of the trial will determine the potential pharmacoeconomic benefits and the incidence rate of LCOS resulted by the administration of levosimendan.

The study has enrolled a total of 880 patients.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Tenax Therapeutics CEO John Kelley said: “We are very pleased to reach this milestone after more than two years of hard work, and would like to thank all of the patients and investigators who have taken part in the trial.

“Consistent clinical execution and increased trial visibility has significantly accelerated the enrolment rate during these past 12 months, and we believe the expanded number of patients ensures that we have the best possible chance for success.

“We now look forward to sharing top-line results with you during the next few months, and we are prepared for a near-term NDA submission and commercial effort if the data reads out positively. We continue to believe that levosimendan has the potential to fill an important void in the current treatment paradigm for cardiac surgery.”