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www.fdanews.com/articles/80900-medicure-s-diabetic-hypertension-study-meets-primary-endpoints

MEDICURE'S DIABETIC HYPERTENSION STUDY MEETS PRIMARY ENDPOINTS

September 14, 2005

Medicure has announced that its MC-4232 drug met primary blood pressure and metabolic endpoints in the Phase II MATCHED study. The study evaluated MC-4232, a combination of MC-1 and the ACE inhibitor, lisinopril, in the treatment of coexisting diabetes and hypertension. Based on these positive results, the company plans to move forward with a pivotal Phase III clinical development program for MC-4232.

The results of MATCHED demonstrate the positive clinical effects of MC-4232 on primary and secondary blood pressure endpoints, including both systolic and diastolic measurements: The results of MATCHED also demonstrated the positive clinical effects of MC-4232 on primary and secondary metabolic endpoints, including glycemic control as measured by fasting serum glucose and glycated hemoglobin, as well as lipid control, after 16 weeks of treatment.

On all key metabolic and blood pressure endpoints the 300 mg/20 mg and 1000 mg/20 mg doses of MC-4232 demonstrated comparable clinical efficacy. The study results also demonstrated that MC-4232 was safe and well tolerated at all dose levels.