The Medicines Company said it plans to resume a Phase III trial of clevidipine, its intravenous, short-acting antihypertensive agent. Researchers announced a voluntary suspension "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, available at that time, showed atrial fibrillation rates of 25 percent on clevidipine and 15 percent on comparator agents... The completed data show atrial fibrillation rates of 34 percent and 31 percent in clevidipine and comparator groups respectively, with no differences in duration, severity, treatments or outcomes reported. Other safety measures in the trial were also satisfactory."
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