Medicines Co. to resume clevidipine phase III trials

By E. Janene Geiss

Philadelphia, Oct. 19 - The Medicines Co. announced Wednesday that it is resuming the phase III clinical safety trials of clevidipine, an intravenous, short-acting antihypertensive agent.

The trials are resuming after a more detailed analysis of interim safety results showed there was in fact no significant differences between clevidipine and comparator treatments in incidence of atrial fibrillation, according to a news release.

The company voluntary suspended patient enrollment of the trial in March after preliminary data from an interim analysis contained more frequent reports of atrial fibrillation in patients randomized in clevidipine than in patients randomized to comparator drugs, officials said.

The preliminary data available at the time from 750 patients showed atrial fibrillation rates of 25% on clevidipine and 15% on comparator agents. Both rates are well within the ranges reported in cardiac surgery literature, officials said.

Completed data included 880 patients and a more detailed assessment of atrial fibrillation risk factors, incidence, treatment and outcome. The completed data showed atrial fibrillation rates of 34% in clevidipine and 31% in comparator groups. Other safety measures also were satisfactory, officials said.

"The more detailed data collection shows atrial fibrillation rates consistent with published data and no evidence that clevidipine confers any additional risk over and above cardiac surgery itself," said Jerrold Levy, a clevidipine clinical investigator and director of cardiothoracic anesthesiology and critical care at Emory Healthcare in Atlanta, Ga.

The company said it anticipates completing enrollment of the resumed safety studies in the next 12 months. Pivotal clinical efficacy studies were completed successfully in 2004 and met prespecified protocol objectives.

Clevidipine is an intravenous L-calcium channel blocker that may prove useful in the treatment of hypertension associated with cardiac surgery.

The Medicines Co. is a Parsippany, N.J.-based pharmaceutical company focused on developing products that improve acute hospital care.

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