An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
Status:
Completed
Trial end date:
2020-09-27
Target enrollment:
Participant gender:
Summary
The purpose of the study is to evaluate the efficacy and safety of the study drug relative to
an active comparator losartan which is in the same class of drug and is approved for use in
the pediatric population aged 6 years and older. Approximately 260 subjects will participate
in a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind,
randomized, placebo-controlled withdrawal phase. A 44-week, open-label extension in which all
subjects will receive azilsartan and other antihypertensive medications (if needed). Blood
pressure will be assessed throughout the study.