Cleviprex is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting. If approved for marketing, the drug will be the first of a third generation of intravenous dihydropyridine calcium channel blockers which works by widening the artery with minimal effect on heart rate.
Clive Meanwell, chairman and CEO of The Medicines Company, said: “With successful completion of this program, we look forward to presentation of the data by investigators. We anticipate submitting an application for Cleviprex US marketing approval in the first half of 2007 and also commencing phase IV studies of Cleviprex in 2007.”
The safety trials are a series of evaluations enrolling 1,500 patients in the perioperative treatment of hypertension. For the primary safety objectives, investigators measured the incidences of death, stroke, myocardial infarction and renal dysfunction. The secondary objectives were to evaluate the adverse experiences with Cleviprex and its blood pressure lowering effect.