The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.
The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,005
150/12.5 mg tablets one or two tablets orally per day
Sanofi-Aventis
Bridgewater, New Jersey, United States
Change in the mean SBP
Time frame: from baseline to week 18
Change in mean DBP
Time frame: from baseline to week 18.
Changes in mean SBP and DBP
Time frame: from baseline to week 10
SBP and DBP response and control rates
Time frame: at weeks 10 and 18
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