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

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Azilsartan	Azilsartan (TAK-536)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)	Up to 12 Months	An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Changes from Baseline in Blood Pressure	Baseline, up to Months 12	Changes from baseline in blood pressure will be calculated by (test value at each test time point after baseline - test value at baseline).
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)	Up to 12 Months	An adverse event is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product (including an investigational product for a new indication in Japan), whether or not related to the pharmaceutical product. For regenerative medicine products, any failure report is also handled as an adverse event.
Actual Measured Value of Blood Pressure	Baseline, up to Months 12

Secondary Outcome Measures

Name	Time	Method

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