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

JRCT ID: jRCT2031210414

Registered date:08/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 16/12/2021
• Target sample size: 5
• Study type: Observational

Outcome(s)

Primary Outcome

1.Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: Up to 12 Months
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.

2.Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)
Time Frame: Up to 12 Months
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.

3.Actual Measured Value of Blood Pressure
Time Frame: Baseline, up to Months 12

4.Changes from Baseline in Blood Pressure
Time Frame: Baseline, up to Months 12
Changes from baseline in blood pressure will be calculated by (test value at each test time point after baseline - test value at baseline).

• Secondary Outcome: N/A

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 16age old
• Gender: Both

Include criteria

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

• Exclude criteria: Participants with contraindications to azilsartan.

Related Information

• Primary Sponsor: Contact for Clinical Trial Information
• Secondary ID(s): NCT05107960