Oxygen Biotherapeutics, Inc. ("OBI") (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the protocol of their phase 3 trial for levosimendan has been published on ClinicalTrials.gov, "Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Heart Surgery on Cardiopulmonary Bypass."
Oxygen Biotherapeutics previously announced that it had selected Duke University's Duke Clinical Research Institute (DCRI) to conduct the Phase 3 trial of the levosimendan. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass grafts (CABG) and/or mitral valve surgery who are at risk for developing low cardiac output syndrome (LCOS). The trial is a double blind, randomized, placebo controlled study seeking to enroll 760 patients.
The number of patients to be enrolled in the trial is an estimate. This is an event driven trial, and will be stopped when the event rate reaches that identified in the study power calculations. Thus, the number of patients could be less than 760 or higher if the event rate is higher or lower than expected.
The protocol includes a review of the control arm event rate for the first 200 patients randomized in the trial. The study population can be enriched to a higher percentage of patients with a greater degree of left ventricular dysfunction to increase the control event rate.
Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.
John Kelley, CEO of Oxygen Biotherapeutics stated: "We are excited to communicate the details of our innovative and efficient trial design , and we look forward to enrolling the first patients in this important trial later this year."
Source: Oxygen Biotherapeutics, Inc.