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

Takeda5 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypertension

Interventions

Azilsartan (TAK-536)DRUG

Azilsartan Tablets, Azilsartan Granules

Eligibility

Sex: ALLMin age: 6 YearsMax age: 15 Years

Outcomes

Primary Outcomes

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.

Time frame: Up to Months 12

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.

Time frame: Up to Months 12

Mean Value of Systolic Blood Pressure

Time frame: Up to 12 Months

Mean Value of Diastolic Blood Pressure

Time frame: Up to 12 Months

Change From Baseline in Mean Value of Systolic Blood Pressure

Time frame: Baseline, Up to 12 Months

Change From Baseline in Mean Value of Diastolic Blood Pressure