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Daiichi Sankyo, Lilly to Conduct Phase III Study Against Plavix

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Daiichi Sankyo Co., Ltd. and Eli Lilly plan to begin a large Phase III trial in 2Q2008 to compare prasugrel, an investigational oral antiplatelet agent, against Bristol-Myers Squibb’s clopidogrel (Plavix/Iscover) in medically managed patients with acute coronary syndrome (ACS), a group of common heart conditions that includes unstable angina (chest pain) and heart attacks.

The multi-center, double-blind, randomized trial will include approximately 10,000 patients in 35 countries. TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes) will evaluate the safety and efficacy of prasugrel against clopidogrel in reducing the risk of cardiovascular death, heart attack or stroke in ACS patients who are to be medically managed without revascularization (a procedure to reopen blocked arteries). Currently, more than 50% of patients with ACS worldwide are managed without acute intervention.

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