The Medicines Company has voluntarily suspended patient enrollment in its Clevelox (clevidipine) 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 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 post-operative day following cardiac surgery in about 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.
Clive Meanwell, Chairman and CEO of The Medicines Company, stated, “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. We have analyzed the interim top-line data – these and further analyses will guide our next steps. In any case, we believe further clinical studies are needed to sort out the meaning of the interim findings – and that will delay our NDA beyond 2005.”
John Kelley, President and COO of The Medicines Company, added, “While surprising, this setback in Clevelox development will not divert our attention away from driving Angiomax revenue growth. We remain on track for 2005 sales goals and expect to remain that way.”
The Clevelox Phase III program is comprised of five clinical trials. The two efficacy studies known as ESCAPE were completed in 2004 and met their pre-specified trial objectives. The safety trials, know as ECLIPSE, are evaluating Clevelox perioperatively (immediately before, during and after surgery) in approximately 1,500 patients. The primary objective of ECLIPSE is to establish the safety of Clevelox in the treatment of perioperative high blood pressure, as measured by a comparison of the incidences of death, stroke, myocardial infarction and renal dysfunction between the Clevelox and comparative treatment groups. The comparative treatments are nitroglycerin, sodium nitroprusside and nicardipine.
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