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Pivotal Phase III Findings With Investigational Drug Cleviprex,(Clevidipine) Demonstrate Perioperative Blood Pressure Control In,Cardiac Surgery

First Presentation of Comparative Data from ECLIPSE, Largest Safety Program of Intravenous Antihypertensive Agents

NEW ORLEANS, March 27, 2007 /PRNewswire-FirstCall/ -- Favorable findings of the investigational drug Cleviprex(TM) (clevidipine) compared to current intravenous antihypertensive agents in controlling perioperative hypertension -- a potentially harmful elevation in blood pressure just before, during and/or after surgery -- were presented for the first time at a late-breaking session here at the 56th Annual Scientific Session of the of Cardiology. The findings were from ECLIPSE*, the largest safety program to date comparing intravenous antihypertensive therapies.

"This analysis from ECLIPSE showed tight perioperative blood pressure control with Cleviprex," said lead author of the presentation, Solomon Aronson, MD, Duke University Medical Center**. "If approved, Cleviprex may provide a potentially important new treatment option for acute hypertension, a condition which affects nearly 3 million people in the U.S. each year."

"We are extremely pleased with the favorable findings of Cleviprex in the ECLIPSE program," said John Kelley, President and Chief Operating Officer of The Medicines Company. "Given the trial successfully met all of its primary endpoints, this marks the completion of our Phase III efforts for Cleviprex. The Medicines Company remains committed and on track to expeditiously move forward with an NDA submission before the end of June."

Study and Findings

The ECLIPSE program included a total of 1,964 cardiac surgery patients each enrolled in one of three randomized, open-label trials comparing Cleviprex to current intravenous antihypertensive agents: nitroglycerin, sodium nitroprusside or nicardipine (ECLIPSE-NTG, ECLIPSE-SNP and ECLIPSE-NIC trials, respectively). Beginning just before surgery, investigators monitored patients' blood pressure (BP) and administ
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