Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients with Hypertension

Background: The prevalence and importance of hypertension in younger patients is becoming increasingly recognized; however, only a limited number of clinical trials have been conducted in the pediatric population. Objective: The aim of this study was to characterize the pharmacokinetics and short-term safety of olmesartan medoxomil in children and adolescents with hypertension. Methods: An open-label, multicenter, single-dose study was conducted in children and adolescents aged 12 months–16 years who were receiving treatment for hypertension or, if not currently treated for hypertension, had either a systolic blood pressure (SBP) or diastolic blood pressure (DBP) ≤95th percentile, or SBP or DBP ≤90th percentile if diabetic or with a family history of hypertension. Patients were stratified by age: 12–23 months (Group 1; none enrolled), 2–5 years (Group 2; n = 4), 6–12 years (Group 3; n = 10), and 13–16 years (Group 4; n = 10). All patients received a single oral dose of olmesartan medoxomil based on the individual’s age and bodyweight. Patients aged