A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years with Hypertension

A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age with Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223205

Enrollment

Registered

2016-05-18

Start date

2016-08-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric hypertension

Interventions

investigational material(s) Generic name etc : TAK-536 INN of investigational material : Azilsartan Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational mate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. In the opinion of the investigator or subinvestigator, the participant's parent or the participant's legal guardian is capable of understanding and complying with protocol requirements. 2. The participant's parent or the participant's 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 Japanese participant who has a diagnosis of hypertension. A participant is eligible if he/she is deemed hypertensive according to the Reference Blood Pressure Values of Children by Gender and Age; office sitting diastolic or systolic blood pressure >= 95 percentile for essential hypertension without concomitant hypertensive organ damage, and >= 90 percentile for secondary hypertension with concomitant chronic kidney disease (CKD), diabetes mellitus, heart failure or any hypertensive organ damage. In addition, participants need to meet the following criteria: (1) If currently treated with any antihypertensive drugs at the start of the Run-in Period: Participant has a documented historical diagnosis of hypertension and an office sitting diastolic or systolic blood pressure meeting the above criteria at the end of the Run-in Period (Week 0). (2) If currently untreated with any antihypertensive drugs at the start of the Run-in Period: Participant who meets the above criteria on 3 separate time points including screening and the end of the Run-in Period (Week 0). In addition, participant with essential hypertension without concomitant hypertensive organ damage still maintains hypertension with non-pharmacotherapy including foods or exercises for at least 3 months within 1 year prior to the start of screening. 4. The participant is male or female and aged 6 to less than 16 years at the time of informed consent. 5. The participant weighs at least 20 kg at screening. 6. The participant is capable of taking the tablets or granules supplied as the study drug. 7. A participant who has undergone kidney transplantation is eligible if he/she underwent the transplantation at least 6 months earlier at screening, and the graft has been functionally stable (estimated glomerular filtration rate [eGFR] >= 30 mL/min/1.73 m^2) for at least 6 months with evidence (eg, Doppler echography, computed tomography (CT) scan or magnetic resonance imaging (MRI)) excluding grafted kidney arterial stenosis. A participant on immunosuppressive therapy with a stable dose at least 30 days prior to screening is eligible. 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 through 1 month after the completion of the study, and proves negative in the pregnancy test at screening. 9. The participants judged by the investigator or subinvestigator that he/she can discontinue the therapy with renin-angiotensin-system ( RAS) inhibitors for 2 weeks (acceptable range, 1 to 4 weeks) in safe prior to the Treatment Period.

Exclusion criteria

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 invasive therapy. 2. The participant previously received therapy with azilsartan. Note: This does not apply to participants participating in single dose pharmacokinetic studies of TAK-536. 3. The participant has poorly controlled hypertension indicated by an office sitting systolic blood pressure higher by at least 15 mmHg and/or an office sitting diastolic blood pressure higher by at least 10 mmHg than the 99 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 ( 130%) with the study drug during the Run-in Period. 6. The participant has severe renal dysfunction (eGFR 9.0% at screening. 11. The participant has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level >= 2.5 x the upper limit of normal (ULN), or a total bilirubin level >= 1.5 x 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 angiotensin II receptor blocker (ARBs). 15. The participant needs treatment with any of the excluded medication. 16. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after the completion of this study.

Design outcomes

Primary

Measure	Time frame
safety Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) Time Frame: Up to Week 54 An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug. safety Number of Participants With TEAEs related to anthropometric measurements (weight, height and BMI) Time Frame: Up to Week 54 safety Number Of Participants With Markedly Abnormal Values of Laboratory Parameters Time Frame: Up to Week 54 The laboratory values outside the range (Blood Urea Nitrogen (BUN) (mg/dL) >30, Creatinine (mg/dL) >2.0, eGFR (mL/min/1.73m^2) 5xULN) are considered markedly abnormal. safety Number of Participants with TEAEs related to resting 12-lead Time Frame: Up to Week 54 A standard 12-lead ECG was performed while the participant was at rest. Any abnormal ECG findings determined by the investigator to be clinically significant were reported as adverse events. safety confirmatory Number of Participants with TEAEs related to vital signs Time Frame: Up to Week 54	—

Measure

Time frame

safety Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) Time Frame: Up to Week 54 An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug. safety Number of Participants With TEAEs related to anthropometric measurements (weight, height and BMI) Time Frame: Up to Week 54 safety Number Of Participants With Markedly Abnormal Values of Laboratory Parameters Time Frame: Up to Week 54 The laboratory values outside the range (Blood Urea Nitrogen (BUN) (mg/dL) >30, Creatinine (mg/dL) >2.0, eGFR (mL/min/1.73m^2) 5xULN) are considered markedly abnormal. safety Number of Participants with TEAEs related to resting 12-lead Time Frame: Up to Week 54 A standard 12-lead ECG was performed while the participant was at rest. Any abnormal ECG findings determined by the investigator to be clinically significant were reported as adverse events. safety confirmatory Number of Participants with TEAEs related to vital signs Time Frame: Up to Week 54

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Secondary

Measure	Time frame
efficacy Office trough sitting systolic blood pressure Time Frame: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), End-of-treatment (EOT) 1 (Up to Week 12), EOT 2 (Up to Week 52) Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. efficacy Office trough sitting diastolic blood pressure Time Frame: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), End-of-treatment (EOT) 1 (Up to Week 12), EOT 2 (Up to Week 52) Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. efficacy Percentage of participants who achieve the target blood pressure Time Frame: Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52) Target blood pressure is defined as the normal reference range for blood pressure by age according to Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012). pharmacokinetics Observed Plasma Concentration for Azilsartan Time Frame: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16 Reported data were observed plasma concentration for Azilsartan for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants. pharmacokinetics Observed Plasma Concentration for Azilsartan metabolites (M-I) Time Frame: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16 Reported data were observed plasma concentration for Azilsartan f	—

Measure

Time frame

efficacy Office trough sitting systolic blood pressure Time Frame: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), End-of-treatment (EOT) 1 (Up to Week 12), EOT 2 (Up to Week 52) Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. efficacy Office trough sitting diastolic blood pressure Time Frame: Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), End-of-treatment (EOT) 1 (Up to Week 12), EOT 2 (Up to Week 52) Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. efficacy Percentage of participants who achieve the target blood pressure Time Frame: Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52) Target blood pressure is defined as the normal reference range for blood pressure by age according to Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012). pharmacokinetics Observed Plasma Concentration for Azilsartan Time Frame: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16 Reported data were observed plasma concentration for Azilsartan for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants. pharmacokinetics Observed Plasma Concentration for Azilsartan metabolites (M-I) Time Frame: Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16 Reported data were observed plasma concentration for Azilsartan f

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026