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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05107960
• Other study ID #: TAK-536-4001
• Secondary ID: jRCT2031210414
• Status: Active, not recruiting
• Start date: December 16, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria

1. Participants aged 6 years or older and less than 16 years

2. Participants with hypertension

Exclusion Criteria Participants with contraindications to azilsartan.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Azilsartan (TAK-536)
Azilsartan Tablets, Azilsartan Granules

Locations

Country	Name	City	State
Japan	Takeda selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 12 Months
Primary	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 12 Months
Primary	Actual Measured Value of Blood Pressure		Baseline, up to Months 12
Primary	Changes from Baseline in Blood Pressure	Changes from baseline in blood pressure will be calculated by (test value at each test time point after baseline - test value at baseline).	Baseline, up to Months 12

External Links

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