The Medicines Company Suspends Enrollment in Clevelox Safety Trials
The Medicines Company has voluntarily suspended patient enrollment in its Clevelox Phase III safety trials.
Trial enrollment was halted after a planned interim analysis of approximately half of the study population showed more frequent atrial fibrillation among patients randomized to Clevelox (clevidipine) than patients randomized to comparator drugs. The interim analysis did not show any other unexpected safety findings.
Clevelox is an investigational drug undergoing Phase III clinical trials as an agent to reduce blood pressure in cardiac surgery. Atrial fibrillation is a form of irregular heartbeat that generally occurs on the second or third postoperative day following cardiac surgery in roughly one-third of patients. The incidence of atrial fibrillation among patients randomized to Clevelox in the Phase III trials was well within the ranges reported in the cardiac surgery literature.