An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension

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.

Timeline

Start

2015-03-30

Primary completion

2019-11-11

Completion

2019-11-11

Drugs

Indications