Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT05107960
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Special Drug Use Surveillance; AZILVA Tablets and AZILVA Granules 1% in Pediatric Use
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| jRCT2031210414 | REGISTRY | jRCT | View |