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

NCT05107960 | Completed Results

• 2 other identifiers: TAK-536-4001jRCT2031210414
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  Up to Months 12

• Mean Value of Systolic Blood Pressure

  Up to 12 Months

• Mean Value of Diastolic Blood Pressure

  Up to 12 Months

• Change From Baseline in Mean Value of Systolic Blood Pressure

  Baseline, Up to 12 Months

• Change From Baseline in Mean Value of Diastolic Blood Pressure

  Baseline, Up to 12 Months

Study Arms (1)

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.

Drug: Azilsartan (TAK-536)

Interventions

Azilsartan (TAK-536) DRUG

Azilsartan Tablets, Azilsartan Granules

Also known as: AZILVA Tablets, AZILVA Granules 1%

Azilsartan

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda selected site

Tokyo, Japan

Location

Related Links

• To obtain more information on the study, click here/on this link.

MeSH Terms

Conditions

Hypertension

Interventions

azilsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 4, 2021
• Study Start: December 16, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)