Study to assess the blood pressure lowering effects of two doses of telmisartan over a four-week treatment period; to determine potentially effective doses for pediatric patients for future studies; to assess the safety and tolerability of two doses of telmisartan. Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of telmisartan in children and adolescents aged 6 to \<18 years, and to determine if age-related differences exist
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
77
Change from baseline in seated systolic blood pressure (SBP)
Time frame: Baseline, after 4 weeks of treatment
Change from baseline in seated diastolic blood pressure (DBP)
Time frame: Baseline, after 4 weeks of treatment
Response rate of blood pressure
defined as both SBP and DBP \< 95th percentile at the patient's final visit based on age, height, and gender
Time frame: after 4 weeks
Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: 72 hours after last study drug administration
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: 72 hours after last study drug administration
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: 72 hours after last study drug administration
Cavg (Average concentration of the analyte in plasma at steady state)
Time frame: 72 hours after last study drug administration
tmax,ss (time from dosing to maximum concentration at steady state)
Time frame: 72 hours after last study drug administration
AUCτ,ss (area under the concentration time curve of the analyte in plasma at steady state over a uniform dosing interval)
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Time frame: 72 hours after last study drug administration
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: 72 hours after last study drug administration
MRTpo,ss (mean residence time of the analyte in the body at steady state)
Time frame: 72 hours after last study drug administration
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: 72 hours after last study drug administration
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Time frame: 72 hours after last study drug administration
PTF (peak trough fluctuation)
Time frame: 72 hours after last study drug administration
Number of patients with adverse events
Time frame: up to 45 days