CompletedNot Applicable

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

Japan5 participantsStarted 2021-12-16

Plain-language 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. 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.

Who can participate

Age range

6 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants aged 6 years or older and less than 16 years
. Participants with hypertension

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to Months 12

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

Timeframe: Up to Months 12

Mean Value of Systolic Blood Pressure

Timeframe: Up to 12 Months

Mean Value of Diastolic Blood Pressure

Timeframe: Up to 12 Months

Change From Baseline in Mean Value of Systolic Blood Pressure

Timeframe: Baseline, Up to 12 Months

Change From Baseline in Mean Value of Diastolic Blood Pressure

Timeframe: Baseline, Up to 12 Months

Trial details

NCT IDNCT05107960

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-08-31

Results submitted2025-08-20

View on ClinicalTrials.gov More Hypertension trials

Plain-language summary

What they're measuring

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

Timeframe: Up to Months 12

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

Timeframe: Up to Months 12

Mean Value of Systolic Blood Pressure

Timeframe: Up to 12 Months

Mean Value of Diastolic Blood Pressure

Timeframe: Up to 12 Months

Change From Baseline in Mean Value of Systolic Blood Pressure

Timeframe: Baseline, Up to 12 Months

Change From Baseline in Mean Value of Diastolic Blood Pressure

Timeframe: Baseline, Up to 12 Months