A Phase 3 Pharmacokinetic Study of TAK-536 (Azilsartan) in Pediatric Patients 6 to Less Than 16 Years With Hypertension
Condition: Pediatric Hypertension
MeSH terms: Hypertension
Intervention: Azilsartan
Intervention description: Azilsartan tablets
Intervention MeSH terms: Azilsartan medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of
      TAK-536 (azilsartan) in pediatric patients aged 6 to less than 16 years with hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator or subinvestigator, the participant's parent or
             legal guardian is capable of understanding and complying with the study requirements.

          2. The participant's parent or legal guardian is capable of signing and dating a written
             informed consent form on behalf of the participant prior to the initiation of any
             study procedures. Written informed assent is also obtained from the participant as
             much as possible.

          3. The participant is diagnosed as hypertensive (if the participant is not receiving
             antihypertensive therapy, the diagnosis will be based on the Age- and Gender-Based
             Blood Pressure Reference for Children. Sitting diastolic blood pressure [DBP] or
             systolic blood pressure [SBP] is to be in at least the 95th percentile if essential
             hypertension is present without concurrent hypertensive organ damage and at least the
             90th percentile if secondary hypertension is present with concurrent chronic renal
             disease, diabetes mellitus, heart failure, or hypertensive organ damage).

          4. The participant is male or female and aged 6 to less than 16 years at the time of
             consent.

          5. The participant weighs at least 20 kg during the observation period.

          6. The participant is capable of taking the tablets provided as study drug.

          7. Participants after renal transplants should meet the following conditions:

             At least 6 months has elapsed from the transplant to the start of the observation
             period with stable graft function for more than 6 months (and estimated glomerular
             filtration rate [eGFR] ≥ 30 mL/min/1.73 m^2) and historical documentation (Doppler
             echo or computed tomography [CT], magnetic resonance imaging [MRI], etc.) which verify
             that arterial stenosis is not present in the transplanted kidney. For participants
             receiving immunosuppressive therapy, the dose should have been stable at least 30 days
             before study drug administration.

          8. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use routinely adequate contraception from signing
             of informed consent to within 1 month after the completion of the study and have a
             negative pregnancy test result during the observation period.

        Exclusion Criteria:

          1. The participant received an investigational drug within 30 days prior to the start of
             the observation period or is currently participating in another clinical study or
             post-marketing study.

             Note: This does not apply to participants participating in observational studies
             without interventional or invasive therapy.

          2. The participant is determined to have poorly controlled hypertension (as a general
             guideline, when clinical sitting blood pressure is measured, SBP is to be at least 15
             mmHg higher and/or DBP is to be at least 10 mmHg higher than the 99th percentile in
             the Age- and Gender-Based Blood Pressure Reference for Children).

          3. The participant is diagnosed with malignant hypertension or rapidly progressive
             hypertension.

          4. The participant has severe renal dysfunction (eGFR <30 mL/min/1.73 m^2), dialysis
             treatment, renovascular disease affecting both kidneys or a solitary kidney, severe
             nephrotic syndrome not in remission, or serum albumin <2.5 g/dL.

          5. The participant has a history or clinical manifestations of serious cardiovascular,
             hepatobiliary, gastrointestinal, endocrine (e.g., hyperthyroidism and Cushing's
             syndrome), hematologic, immunologic, genitourinary, or psychiatric disease; cancer;
             and/or any conditions that would interfere with the health status of the participant
             through study participation or would jeopardize study integrity in the opinion of the
             investigator or subinvestigator.

          6. The participant has left ventricular outflow tract obstruction affecting hemodynamics
             due to aortic stenosis, aortic valve disease, or the like or is scheduled to have
             surgery affecting blood pressure (e.g., repair of arterial anomalies) during the
             study.

          7. The participant underwent a surgical procedure with major bleeding within 6 months
             before the start of the observation period.

          8. The participant has past or present clinically significant abnormalities on the
             12-lead electrocardiogram and is ineligible for the study in the opinion of the
             investigator or subinvestigator.

          9. The participant has poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] >9.0%
             during the observation period)

         10. The participant has any of either alanine aminotransferase [ALT] or aspartate
             aminotransferase [AST] at least 2.5 times the upper limit of standard value or total
             bilirubin at least 1.5 times the upper limit of standard value, severe hepatic
             dysfunction, active liver disease (regardless of etiology), and jaundice during the
             observation period.

         11. The participant has hyperkalemia exceeding the upper limit of standard value during
             the observation period.

         12. The participant has a history of hepatitis B, hepatitis C, or human immunodeficiency
             virus infection at the start of the observation period.

         13. The participant has a history of hypersensitivity or allergy to angiotensin II
             receptor blockers (ARBs).

         14. The participant requires treatment with prohibited concomitant drug(s).

         15. Peripheral venous blood collection from the participant is difficult.

         16. The participant had a clinically significant acute disease within 30 days from the day
             before study drug administration.

         17. If female, the participant is pregnant or lactating, or intending to become pregnant
             before giving consent, during the study period, or within 1 month after study
             completion.