Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement). Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM Safety: Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
363
Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment
Time frame: Baseline and week 12
Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study
Time frame: Baseline and week 24
Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval
Time frame: Baseline, week 12 and 24
Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP)
Time frame: Baseline, week 12 and 24
Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP
Time frame: Baseline, week 12 and 24
Changes from baseline in SBP/DBP of 24 hours mean ABPM
Time frame: Baseline, week 12 and 24
Comparison of SBP/DBP ABPM tracing profile
Time frame: Week 12 and 24
Smoothness index in comparison with baseline
Time frame: Baseline, week 12 and 24
Number of responders
Time frame: Week 12 and 24
Number of controlled responders
Time frame: Week 12 and 24
Number of patients who withdraw due to lack of efficacy
Time frame: 24 weeks
Number of patients with adverse events
Time frame: 24 weeks
Number of patients who withdraw due to adverse events
Time frame: 24 weeks
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