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

An observational study of Hypertension, run by Takeda at 1 site in Japan.

Completed

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

Trial summary

The main aim of this study is to check for side effects from treatment with azilsartan and how well azilsartan controls blood pressure in children from 6 to less than 16 years old with high blood pressure. Read more about this study

Who is it for?: Ages 6 to 15 years
Conditions the study is for: Hypertension
What is being tested?: Azilsartan (TAK-536)
Type of treatment: Pill or oral medicine
How many people: 5 participants
Where: 1 siteJapan
Study dates: 16 Dec 2021to 31 Aug 2024
Phase: Observational
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

Study population: Children with hypertension aged 6 years or older and less than 16 years will be included in the survey.

Who may be able to join

Participants aged 6 years or older and less than 16 years
Participants with hypertension
Exclusion Criteria Participants with contraindications to azilsartan.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda selected site
Tokyo

Other trials in Japan

About this study

Official title: Special Drug Use Surveillance; AZILVA Tablets and AZILVA Granules 1% in Pediatric Use

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with high blood pressure will take azilsartan tablets or azilsartan granules once a day according to their clinic's standard practice. The study doctors will check for side effects from azilsartan for up to 12 months after treatment starts.

Conditions: Hypertension
Being tested: Azilsartan (TAK-536)
Medical subject headings: Hypertension

What participants receive

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

Azilsartan (TAK-536)Drug
Also called AZILVA Tablets, AZILVA Granules 1%
Azilsartan Tablets, Azilsartan Granules

Study groups in NCT05107960
Study group	Role	What they receive
Azilsartan		Azilsartan tablets or granules formulation, orally once daily. For children aged 6 years or older, the usual initial oral dosage of azilsartan is 2.5 mg and 5 mg once daily for those weighing <50 kg and >=50 kg, respectively. Receives: Drug: Azilsartan (TAK-536)

What is being measured

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

Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
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.
Measured: Up to Months 12
Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)
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.
Measured: Up to Months 12
Mean Value of Systolic Blood Pressure
Measured: Up to 12 Months
Mean Value of Diastolic Blood Pressure
Measured: Up to 12 Months
Change From Baseline in Mean Value of Systolic Blood Pressure
Measured: Baseline, Up to 12 Months
Change From Baseline in Mean Value of Diastolic Blood Pressure
Measured: Baseline, Up to 12 Months

Timeline

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

16 Dec 202131 Aug 2024

First posted4 Nov 2021
Study start16 Dec 2021
Primary completion31 Aug 2024
Study completion31 Aug 2024

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.
Other trials for 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05107960
Sponsor's protocol ID: TAK-536-4001
Other IDs: jRCT2031210414
Status last verified: Sep 2025
First submitted: 28 Oct 2021
Last updated: 10 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).

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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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Drug Use Surveillance; AZILVA Tablets and AZILVA Granules 1% in Pediatric Use
ClinicalTrials.gov ID: NCT05107960
Acronym / sponsor ID: TAK-536-4001
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 16 Dec 2021 (actual)
Primary completion: 31 Aug 2024 (actual)
Study completion: 31 Aug 2024 (actual)
First posted: 4 Nov 2021 (actual)
Results: Posted 10 Sep 2025

Clinical summary

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

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Azilsartan	–	Drug: Azilsartan (TAK-536)Azilsartan tablets or granules formulation, orally once daily. For children aged 6 years or older, the usual initial oral dosage of azilsartan is 2.5 mg and 5 mg once daily for those weighing <50 kg and >=50 kg, respectively.

Who may qualify

Ages: 6 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Children with hypertension aged 6 years or older and less than 16 years will be included in the survey.

Key inclusion criteria (3 listed)

Participants aged 6 years or older and less than 16 years
Participants with hypertension
Exclusion Criteria Participants with contraindications to azilsartan.

Key exclusion criteria (0 listed)

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
Azilsartan (TAK-536)Also: AZILVA Tablets, AZILVA Granules 1%Azilsartan Tablets, Azilsartan Granules	Drug	Azilsartan

Primary outcome

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.
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.
Mean Value of Systolic Blood Pressure
Time frame: Up to 12 Months
Mean Value of Diastolic Blood Pressure
Time frame: Up to 12 Months
Change From Baseline in Mean Value of Systolic Blood Pressure
Time frame: Baseline, Up to 12 Months
Change From Baseline in Mean Value of Diastolic Blood Pressure
Time frame: Baseline, Up to 12 Months

Results and safety

Results posted to the registry on 10 Sep 2025, 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	5

Primary outcome: Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)

Time frame: Up to Months 12. Count of participants. Unit: Participants

Measure	Azilsartan n = 5
Value	0

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)

Time frame: Up to Months 12. Count of participants. Unit: Participants

Measure	Azilsartan n = 5
Value	0

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Primary outcome: Mean Value of Systolic Blood Pressure

Time frame: Up to 12 Months. Mean (Standard Deviation). Unit: mmHg

Measure	Azilsartan n = 5
Baseline	121.8 (10.47)
Month 1	109.8 (17.90)
Month 2	112.3 (24.01)
Month 3	117.5 (20.51)
Month 4	113.3 (6.90)
Month 5	115.5 (3.54)
Month 6	97.0 (NA)
Month 7	116.5 (13.44)

Population analysed: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure.

Primary outcome: Mean Value of Diastolic Blood Pressure

Time frame: Up to 12 Months. Mean (Standard Deviation). Unit: mmHg

Measure	Azilsartan n = 5
Baseline	72.8 (10.31)
Month 1	65.8 (9.78)
Month 2	68.0 (12.00)
Month 3	77.5 (3.54)
Month 4	64.0 (8.76)
Month 5	58.5 (0.71)
Month 6	61.0 (NA)
Month 7	57.0 (11.31)

Adverse events

Time frame: Up to 12 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azilsartan	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this link.Link provided by the sponsor.
Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

Study Director study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Takeda at 1 site 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 3 inclusion and 0 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2025). 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?

Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: Up to Months 12). The study lists 6 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 NCT05107960.

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 10 Sep 2025.