The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
490
Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose
Time frame: after 6 to 8 weeks
Change in the mean DBP during the last 6 hours of the 24-hour dosing interval, as measured by ABPM after an active dose of study medication
Time frame: after 6 to 8 weeks
Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose
Time frame: after 6 to 8 weeks
Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment
Time frame: after 6 to 8 weeks
Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose
Time frame: 8 weeks
Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose
Time frame: 8 weeks
Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose
Time frame: 8 weeks
Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after an active dose
Time frame: 8 weeks
Responder rates based on ABPM
Time frame: after 6 to 8 weeks
Responder rates based on in-clinic trough cuff blood pressures
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Time frame: after 6 to 8 weeks