A Study of Azilsartan in Children from 6 to Less Than 16 Years Old with High Blood Pressure

Last updated: September 30, 2024
Sponsor: Takeda
Overall Status: Completed

Phase

N/A

Condition

Circulation Disorders

Williams Syndrome

Stress

Treatment

Azilsartan (TAK-536)

Clinical Study ID

NCT05107960
TAK-536-4001
jRCT2031210414
  • Ages 6-15
  • All Genders

Study Summary

The main aim of this study is to check for side effects from treatment with azilsartan and how well azilsartan controls blood pressure in children from 6 to less than 16 years old with high blood pressure.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with high blood pressure will take azilsartan tablets or azilsartan granules once a day according to their clinic's standard practice. The study doctors will check for side effects from azilsartan for up to 12 months after treatment starts.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Participants aged 6 years or older and less than 16 years

  2. Participants with hypertension

Exclusion Criteria Participants with contraindications to azilsartan.

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Azilsartan (TAK-536)
Phase:
Study Start date:
December 16, 2021
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Takeda selected site

    Tokyo,
    Japan

    Site Not Available

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