Pediatric HypertensionPhase 3NCT02451150

A Phase 3 Pharmacokinetic Study of TAK-536 (Azilsartan) in Pediatric Patients 6 to Less Than 16 Years With Hypertension

A Phase 3 study testing Azilsartan in people with Pediatric Hypertension, run by Takeda at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 6 to 15 years
Conditions the study is for: Pediatric Hypertension
What is being tested?: Azilsartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 3 sitesJapan
Study dates: Aug 2015to Sep 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.
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.
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).
The participant is male or female and aged 6 to less than 16 years at the time of consent.
The participant weighs at least 20 kg during the observation period.
The participant is capable of taking the tablets provided as study drug.

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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.
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.

Who cannot join

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.
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).
The participant is diagnosed with malignant hypertension or rapidly progressive hypertension.
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.
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.

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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.
The participant underwent a surgical procedure with major bleeding within 6 months before the start of the observation period.
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.
The participant has poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] >9.0% during the observation period)
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.
The participant has hyperkalemia exceeding the upper limit of standard value during the observation period.
The participant has a history of hepatitis B, hepatitis C, or human immunodeficiency virus infection at the start of the observation period.
The participant has a history of hypersensitivity or allergy to angiotensin II receptor blockers (ARBs).
The participant requires treatment with prohibited concomitant drug(s).
Peripheral venous blood collection from the participant is difficult.
The participant had a clinically significant acute disease within 30 days from the day before study drug administration.
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.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Study site
Fuchū
Study site
Oofu
Study site
Setagaya-ku

Other trials in Japan

About this study

Official title: An Open-label, Phase 3, Multicenter Study to Evaluate the Pharmacokinetics Following a Single Oral Dose of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

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.

Read the detailed description

The drug being tested in this study is called azilsartan. Azilsartan was being tested to evaluate how it is processed by the body (pharmacokinetics). This study looked at lab results in pediatric participants who took azilsartan.

The study enrolled 6 patients. Participants were assigned to study medication dose by body weight as follows:

Body Weight <50 kg: azilsartan 5 mg
Body Weight ≥50 kg: azilsartan 10 mg

All participants took a single oral dose of azilsartan on Day 1 of the study.

This multi-center trial was conducted in Japan. The overall time to participate in this study was 17 days. Participants made multiple visits to the clinic, and were contacted by telephone on Day 6 and Day 15 after last dose of study drug for a follow-up assessment.

Conditions: Pediatric Hypertension
Being tested: Azilsartan
Keywords: Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzilsartanDrug
Also called TAK-536
Azilsartan tablets

Study groups in NCT02451150
Study group	Role	What they receive
Azilsartan 5 mg	Experimental	Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1. Receives: Drug: Azilsartan
Azilsartan 10 mg	Experimental	Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1. Receives: Drug: Azilsartan

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan)
AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan)
Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan)
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan)
Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan)
T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-I
AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-I
Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-I
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-I
Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-I
T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-II
AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-II
Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-II
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-II
Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-II
T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan)
The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 will be calculated from the urinary concentration and volume of each participant.
Measured: Day 1 from 0 to 24 hours post-dose
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-I
The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-I will be calculated from the urinary concentration and volume of each participant.
Measured: Day 1 from 0 to 24 hours post-dose
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-II
The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-II will be calculated from the urinary concentration and volume of each participant.
Measured: Day 1 from 0 to 24 hours post-dose
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
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 (example, 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. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Measured: Up to 15 Days
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Vital Signs
Vital signs are defined as sitting blood pressure, sitting pulse rate and temperature.
Measured: Baseline and Day 2
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Body Weight
Measured: Baseline and Day 2
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Resting 12-Lead Electrocardiogram (ECG)
A resting 12-lead ECG was recorded. The investigator or subinvestigator (or a qualified physician at the study site) interpreted the ECG results.
Measured: Baseline and Day 2
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Laboratory Test Results
Laboratory test results are defined as serum chemistry, hematology and urinalysis.
Measured: Baseline and Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Sep 2015

First posted21 May 2015 (estimated)
Study startAug 2015
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pediatric HypertensionStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02451150
Sponsor's protocol ID: TAK-536/CPH-103
Other IDs: U1111-1169-6319, JapicCTI-152898
Status last verified: Mar 2016
First submitted: 19 May 2015
Last updated: 7 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Enya K, Saji BT, Kato T, Okamoto H, Koumura E. Pharmacokinetics of a Single Dose of Azilsartan in Pediatric Patients: A Phase 3, Open-Label, Multicenter Study. Adv Ther. 2018 Aug;35(8):1181-1190. doi: 10.1007/s12325-018-0754-5. Epub 2018 Jul 19.
PubMed 30027478

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Phase 3, Multicenter Study to Evaluate the Pharmacokinetics Following a Single Oral Dose of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension
ClinicalTrials.gov ID: NCT02451150
Acronym / sponsor ID: TAK-536/CPH-103
Conditions: Pediatric Hypertension
Keywords: Drug therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 21 May 2015 (estimated)
Results: Posted 7 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The study enrolled 6 patients. Participants were assigned to study medication dose by body weight as follows:

Body Weight <50 kg: azilsartan 5 mg
Body Weight ≥50 kg: azilsartan 10 mg

All participants took a single oral dose of azilsartan on Day 1 of the study.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Azilsartan 5 mg	Experimental	Drug: AzilsartanWeight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
Azilsartan 10 mg	Experimental	Drug: AzilsartanWeight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.

Who may qualify

Ages: 6 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

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.
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.
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).
The participant is male or female and aged 6 to less than 16 years at the time of consent.
The participant weighs at least 20 kg during the observation period.

Key exclusion criteria (18 listed)

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.
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).
The participant is diagnosed with malignant hypertension or rapidly progressive hypertension.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AzilsartanAlso: TAK-536Azilsartan tablets	Drug	Azilsartan 10 mg, Azilsartan 5 mg

Primary outcome

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan)
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan)
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan)
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan)
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan)
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-I
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-I
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-I
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-I
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-I
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-II
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-II
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-II
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-II
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-II
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose
T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan)
Time frame: Day 1 from 0 to 24 hours post-dose
The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 will be calculated from the urinary concentration and volume of each participant.
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-I
Time frame: Day 1 from 0 to 24 hours post-dose
The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-I will be calculated from the urinary concentration and volume of each participant.
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-II
Time frame: Day 1 from 0 to 24 hours post-dose
The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-II will be calculated from the urinary concentration and volume of each participant.
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Up to 15 Days
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 (example, 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. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Vital Signs
Time frame: Baseline and Day 2
Vital signs are defined as sitting blood pressure, sitting pulse rate and temperature.
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Body Weight
Time frame: Baseline and Day 2
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Resting 12-Lead Electrocardiogram (ECG)
Time frame: Baseline and Day 2
A resting 12-lead ECG was recorded. The investigator or subinvestigator (or a qualified physician at the study site) interpreted the ECG results.
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Laboratory Test Results
Time frame: Baseline and Day 2
Laboratory test results are defined as serum chemistry, hematology and urinalysis.

Results and safety

Results posted to the registry on 7 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azilsartan 5 mg	3	3
Azilsartan 10 mg	3	3

Primary outcome: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan)

Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Azilsartan 5 mg n = 3	Azilsartan 10 mg n = 3
Value	6350.3 (2963.53)	6871.7 (893.93)

Population analysed: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Primary outcome: Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan)

Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Azilsartan 5 mg n = 3	Azilsartan 10 mg n = 3
Value	888.3 (291.11)	831.3 (180.79)

Population analysed: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Primary outcome: AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan)

Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Azilsartan 5 mg n = 3	Azilsartan 10 mg n = 3
Value	6635.7 (3279.58)	7433.3 (1227.49)

Population analysed: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Primary outcome: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan)

Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose. Median (Full Range). Unit: hours

Measure	Azilsartan 5 mg n = 3	Azilsartan 10 mg n = 3
Value	3.00 (2.1 to 3.0)	4.00 (2.1 to 4.0)

Population analysed: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Adverse events

Time frame: 15 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azilsartan 5 mg	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Azilsartan 10 mg	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30027478Enya K, Saji BT, Kato T, Okamoto H, Koumura E. Pharmacokinetics of a Single Dose of Azilsartan in Pediatric Patients: A Phase 3, Open-Label, Multicenter Study. Adv Ther. 2018 Aug;35(8):1181-1190. doi: 10.1007/s12325-018-0754-5. Epub 2018 Jul 19.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study chair

Takeda

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azilsartan in people with Pediatric Hypertension, run by Takeda at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) (time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02451150, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.