A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure
NCT ID: NCT05107960
Last Updated: 2025-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
5 participants
OBSERVATIONAL
2021-12-16
2024-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Azilsartan (TAK-536)
Azilsartan Tablets, Azilsartan Granules
Interventions
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Azilsartan (TAK-536)
Azilsartan Tablets, Azilsartan Granules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants with hypertension
6 Years
15 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Takeda selected site
Tokyo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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jRCT2031210414
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-536-4001
Identifier Type: -
Identifier Source: org_study_id
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