THE MEDICINES COMPANY RESUMES CLEVIDIPINE PHASE III PROGRAM

The Medicines Company has announced that it is resuming Phase III clinical safety trials of clevidipine, its intravenous, short-acting antihypertensive agent. Review of interim safety results showed no significant differences between clevidipine and comparator treatments. Specifically, the incidence of atrial fibrillation was found to be similar between the randomized groups and in line with published data from other studies. Pivotal clinical efficacy studies were completed successfully in 2004, and met their pre-specified protocol objectives.

In March, the company announced a voluntary suspension of patient enrollment in the Phase III safety trials because preliminary data from an interim analysis contained more frequent reports of atrial fibrillation in patients randomized to clevidipine than in patients randomized to comparator drugs. These preliminary data from 750 patients showed atrial fibrillation rates of 25 percent on clevidipine and 15 percent on comparator agents. Both rates were well within the ranges reported in the cardiac surgery literature.