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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Azilsartan (TAK-536)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Participants aged 6 years or older and less than 16 years Participants with hypertension Exclusion Criteria Participants with contraindications to azilsartan.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Azilsartan<br>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. | Drug: Azilsartan (TAK-536)<br>* Azilsartan Tablets, Azilsartan Granules<br>* Other names: AZILVA Tablets, AZILVA Granules 1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 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. | Up to 12 Months | 
| Number of Participants Who Experienced at Least One Serious Adverse Event (SAE) | 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. | Up to 12 Months | 
| Actual Measured Value of Blood Pressure |  | Baseline, up to Months 12 | 
| Changes from Baseline in Blood Pressure | Changes from baseline in blood pressure will be calculated by (test value at each test time point after baseline - test value at baseline). | Baseline, up to Months 12 |