An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic blood pressure in patients who fail to respond adequately to telmisartan monotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
327
Change from baseline in seated diastolic blood pressure (DBP)
Time frame: baseline and after 8 weeks of treatment
Change from baseline in seated systolic blood pressure (SBP)
Time frame: baseline and after 8 weeks of treatment
Blood pressure control
Time frame: 8 weeks
Systolic blood pressure response
Time frame: 8 weeks
Incidence of adverse events
Time frame: up to 16 weeks
Change from baseline in physical examination
Time frame: Baseline and day 56
Change from baseline in heart rate
Time frame: Baseline, day 28 and 56
Change from baseline in laboratory parameters
Time frame: Baseline and day 56
Change from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline and day 56
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