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Study Design
The study was a double-blind, randomized, placebo-controlled, parallel-group, multi-center titrate-to-goal study. The primary endpoint was change from baseline in mean SBP at study end. The secondary endpoints included change from baseline in mean DBP, and the percent of patients achieving BP goals of < 140/90, < 130/85, < 130/80 and < 120/80 mm Hg at each titration period and study end and a subgroup analysis by baseline stage of hypertension (Stage 1 and Stage 2). Overall mean baseline BP was 157/94 and 155/94 mm Hg for the active treatment and placebo group, respectively.
The patient population of 465 initially entered a 3-4 week single-blind placebo run-in period. Patients who met inclusion criteria (n=276) were then randomized to receive olmesartan (OM) or placebo according to a titration scheme consisting of a 12-week double-blind study period. Patients randomized to olmesartan initially received 20 mg/day. If BP remained greater than or equal to 120/80 mm Hg, patients were uptitrated until BP was normalized. The titration schedule was as follows: OM 40 mg/day (week 4-6), OM/HCTZ 40/12.5 mg/day (week 7-9), and OM/HCTZ 40/25 mg/day (week 10-12). Once BP was controlled to the target level, patients stayed on the medication dosage that achieved this goal. If at any point, patients BP exceeded 120/80, the titration schedule was resumed.
About BENICAR and BENICAR HCT
Angiotensin II is a hormone that interacts with a receptor on arterial
blood vessels, which results in constriction and increasing blood pressure.
In addition, angiotensin II stimulates the release of another hormone that
causes enhanced sodium and chloride (salt) retentio
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