The company said that 15 patients have been randomized and that there have been no serious adverse events reported yet.
Tenax Therapeutics (NASDAQ:TENX) has announced an update on its ongoing clinical trial of levosimendan.
As quoted in the press release:
Tenax is conducting a multi-center, double-blind placebo controlled Phase 2 trial designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). The Company has activated all of its anticipate 15 sites which it believes will be sufficient to fully enroll the trial. 15 patients, up from eight at the end of August, are currently enrolled, out of the targeted 36 patients. Given the current pace of patient enrollment, we continue to expect full enrollment and top-line data in the first quarter of 2020.
The trial has a predefined response criterion that patients must meet following a 24-hour open-label infusion of levosimendan before they can be randomized to the 6-week double-blind phase of the trial. The criterion for randomization is that PCWP measured during supine exercise is ≥ 4mmHg less after the open-label infusion than at baseline. 15 of the 18 patients, approximately 83%, achieved this predefined responder criterion with a mean reduction of 8 mmHg in PCWP.