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

Takeda

Status: Completed

Conditions: Hypertension

Treatments: Drug: Azilsartan (TAK-536)

Study type: Observational

Funder types: Industry

Identifiers

NCT05107960

jRCT2031210414 (Registry Identifier)

TAK-536-4001

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

5 participants in 1 patient group

Azilsartan

Description:

Azilsartan tablets or granules formulation, orally once daily. For children aged 6 years or older, the usual initial oral dosage of azilsartan is 2.5 mg and 5 mg once daily for those weighing \<50 kg and \>=50 kg, respectively.

Treatment:

Drug: Azilsartan (TAK-536)