A Study of TAK-536 in Children From 2 to Less Than 6 Years Old With High Blood Pressure

Exclusion Criteria

• •1. The participant has received any investigational compound within 30 days prior to screening or is participating in another clinical study or a post-marketing clinical study.
• •Note: This does not apply to participants participating in observational studies without interventional or surgical therapy.
• •2. The participant previously received therapy with azilsartan.
• •3. The participant has poorly controlled hypertension indicated by an office sitting systolic blood pressure higher by at least 22 mmHg and/or an office sitting diastolic blood pressure higher by at least 17 mmHg than the 95th percentiles of the reference blood pressure values of children by gender and age.
• •4. The participant has a diagnosis of malignant or accelerated hypertension.
• •5. The participant was noncompliant (compliance: \<70% or \>130%) with the study drug during the Run-in Period. The proportion of the number of the received the study drug to the number of the study drug which the participants should receive.
• •6. The participant has severe renal dysfunction (eGFR \<30 mL/min/1.73 m\^2), is receiving dialysis, has a renovascular disease affecting one or both kidneys, severe nephrotic syndrome not in remission, or a serum albumin level \<2.5 g/dL.
• •7. The participant has a history of, or the signs/symptoms of serious cardiovascular, hepatobiliary, gastrointestinal, endocrine (eg, hyperthyroidism, Cushing's syndrome), hematological, immunological, urogenital, psychiatric disease, cancer, or any other disease that adversely affects participant's health, or, in the opinion of the investigator or subinvestigator, potentially confounds the study results.
• •8. The participant has hemodynamically significant left ventricular outflow obstruction due to aortic stenosis or uncorrected aortic valvular disease, or is scheduled to undergo a medical procedure affecting blood pressure during the study (eg, correction of arterial anomaly).
• •Note: This does not apply to participants who received medical procedure(s) (eg, surgery for aortic coarctation) before the study and investigator or subinvestigator assess that participant's condition is stable at screening.
• •9. The participant has a history of or concurrent clinically significant abnormality of 12-lead ECG that, in the opinion of the investigator or subinvestigator, disqualifies the participant for participation in the study.
• •10. The participant has poorly controlled diabetes mellitus indicated by HbA1c \>9.0% at screening.
• •11. The participant has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \>=2.5 × the upper limit of normal (ULN), or a total bilirubin level \>=1.5 × ULN at screening, severely impaired hepatic function, any active liver disease (regardless of the cause), or jaundice.
• •12. The participant has hyperkalemia exceeding ULN at screening.
• •13. The participant has a history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at screening.
• •14. The participant has a known hypersensitivity or allergy to any ARBs.
• •15. The participant needs treatment with any of the excluded medication.