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

Primary outcomes

1. Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)

   Time frame: Up to Months 12

   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.

2. Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)

   Time frame: Up to Months 12

   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.

3. Mean Value of Systolic Blood Pressure

   Time frame: Up to 12 Months

4. Mean Value of Diastolic Blood Pressure

   Time frame: Up to 12 Months

5. Change From Baseline in Mean Value of Systolic Blood Pressure

   Time frame: Baseline, Up to 12 Months

6. Change From Baseline in Mean Value of Diastolic Blood Pressure

   Time frame: Baseline, Up to 12 Months