The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
1235.31.86001 Boehringer Ingelheim Investigational Site
Shanghai, China
DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean
ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.
Time frame: 8 weeks
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5
Time frame: 8 weeks
Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment
Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.
Time frame: 8 weeks
Change From Baseline to End of Study in DBP and SBP
Manually measured in-clinic DBP and SBP
Time frame: 8 weeks
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment
Time frame: 0 and 8 weeks
Treatment Emergent Adverse Events
Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events
Time frame: 8 weeks
Change From Baseline to End of Study in In-clinic Pulse Rate
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Time frame: 8 weeks