NCT02235909

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: Arbor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of the study is to evaluate the efficacy and safety of the study drug relative to an active comparator losartan which 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. This study also includes a 44-week, open-label extension Phase in which all subjects will receive azilsartan and other antihypertensive medications (if needed) in order to reach an optimal blood pressure. Blood pressure will be assessed in the clinic throughout the study, and subjects may also participate in a 24-hour ambulatory blood pressure monitoring procedure at baseline, at the end of the double-blind Phase and at the end of the open-label Phase.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Azilsartan Medoxomil Low-dose	Azilsartan medoxomil low-dose (AZM-L) 10 mg
DRUG	Losartan
DRUG	Placebo for Azilsartan Medoxomil
DRUG	Placebo for Losartan
DRUG	Azilsartan Medoxomil Medium-dose (20 mg)	Azilsartan medoxomil medium-dose (AZM-M) 20 mg
DRUG	Azilsartan Medoxomil High-dose (40 mg)	Azilsartan medoxomil high-dose (AZM-L) 40 mg

Timeline

• Start date: 2015-03-30
• Primary completion: 2019-11-11
• Completion: 2019-11-11
• First posted: 2014-09-10
• Last updated: 2025-02-25
• Results posted: 2025-02-25

Locations

69 sites across 12 countries: United States, Argentina, Brazil, Bulgaria, Colombia, Hungary, Italy, Mexico, Poland, South Africa, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study