Special Drug Use Surveillance; AZILVA Tablets and AZILVA Granules 1% in Pediatric Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Mean Value of Systolic Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Azilsartan (TAK-536) (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Mean Value of Systolic Blood Pressure
Time Frame: Baseline, Up to 12 Months
Change From Baseline in Mean Value of Diastolic Blood Pressure
Time Frame: Baseline, Up to 12 Months
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: Up to Months 12
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.
Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)
Time Frame: Up to Months 12
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.
Mean Value of Systolic Blood Pressure
Time Frame: Up to 12 Months
Mean Value of Diastolic Blood Pressure
Time Frame: Up to 12 Months
Secondary Outcomes
No secondary outcomes reported