At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension
In Brief
A Phase 3 clinical trial evaluating Azilsartan Medoxomil Low-dose, Losartan, and 4 other interventions for Hypertension. Completed, enrolled 377 participants across 69 sites in 12 countries.
Detailed 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.
Study Details
Timeline
Interventions
Azilsartan medoxomil low-dose (AZM-L) 10 mg
Azilsartan medoxomil medium-dose (AZM-M) 20 mg
Azilsartan medoxomil high-dose (AZM-L) 40 mg