Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in patients with isolated systolic hypertension (ISH), and to assess the dose response relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80 mg. Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability of Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations, heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,039
Change from baseline in seated systolic blood pressure at trough (24 hours post-dose)
Time frame: after 6 weeks of treatment
Change from baseline in urine albumine excretion rate
Time frame: after 6 weeks of treatment
Change from baseline in pulse wave velocity
Time frame: after 6 weeks of treatment
Percentage of patients achieving a target fall in SBP
Time frame: after 6 weeks of treatment
Changes in seated diastolic blood pressure (DBP)
Time frame: up to 6 weeks
Change from baseline in augmentation index
Time frame: after 6 weeks of treatment
Incidence and intensity of adverse events
Time frame: up to 6 weeks
Number of patients with relevant changes from baseline in physical examination
Time frame: baseline, week 6
Number of patients with relevant changes in Heart Rate (HR)
Time frame: up to 6 weeks
Number of patients with relevant changes in laboratory parameters
Time frame: up to 6 weeks
Number of patients with relevant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 6 weeks
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