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Amlodipine and Olmesartan Study Results Released;Late Breaker,Presented at American Society of Hypertension Twenty-Second Annual,Scientific Meeting (ASH 2007)

ith mean reductions of 19.7 mm Hg systolic/12.7 mm Hg diastolic for amlodipine 10 mg alone (placebo= 4.8/3.1 mm Hg). When compared to amlodipine 10 mg alone, amlodipine 10 mg/day plus olmesartan 40 mg/day resulted in a 53 percent greater reduction in systolic blood pressure. Amlodipine combined with olmesartan provides two complimentary mechanisms of action to lower blood pressure: calcium channel blockade with amlodipine and angiotensin receptor blockade with olmesartan.

The AE profile for each of the combinations was similar in nature to the monotherapy components. Most reported treatment-emergent adverse events across all treatment groups were considered mild in severity.

Hypertension, also known as high blood pressure, affects approximately 72 million people in the United States and approximately one billion worldwide. It is often difficult to control, and of those diagnosed with high blood pressure, 64.9 percent do not have the condition under control.1

Study Design

The study was a Phase III, 8-week, randomized, double-blind, placebo-controlled, parallel-group, factorial study in 1,940 patients with mild to severe hypertension defined as seated diastolic BP between ? 95 mm Hg and ? 120 mm Hg. The purpose of the study was to determine if co-administration of amlodipine 5-10 mg/day and olmesartan 10-20-40 mg/day had a significant benefit vs. its respective monotherapy components. Primary and one of the secondary endpoints were mean change from baseline in seated diastolic and seated systolic blood pressure at week 8, respectively.






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