NCT05107960

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

Special Drug Use Surveillance; AZILVA Tablets and AZILVA Granules 1% in Pediatric Use

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Azilsartan (TAK-536)	Azilsartan Tablets, Azilsartan Granules

Timeline

• Start date: 2021-12-16
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2021-11-04
• Last updated: 2025-09-10
• Results posted: 2025-09-10

Locations

1 site across 1 country: Japan