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

NCT02235909 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2025-02-25

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Arbor Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Steve Caras, MD · Arbor Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-30
Primary Completion
2019-11-11
Completion
2019-11-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Colombia
  • Hungary
  • Italy
  • Mexico
  • Poland
  • South Africa
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02235909 on ClinicalTrials.gov