Clevelox is an investigational drug undergoing phase III clinical trials as an agent to reduce blood pressure in cardiac surgery.
Trial enrollment was halted after a planned interim analysis of approximately half of the study population showed more frequent atrial fibrillation (a form of irregular heartbeat) among patients randomized to Clevelox (clevidipine) than patients randomized to comparator drugs (nitroglycerin, sodium nitroprusside and nicardipine).
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 and the interim analysis did not show any other unexpected safety findings.
“We find these results puzzling, because atrial fibrillation rates on Clevelox were not high compared to expectations. However, low reported rates of atrial fibrillation in comparator groups led to a difference we cannot ignore,” stated Clive Meanwell, chairman and CEO of The Medicines Company.
Meanwell also stated that the company’s new drug application (NDA) for Clevelox will now be delayed beyond 2005 as further clinical studies will be needed.