---
title: A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure
nct_id: NCT05107960
overall_status: COMPLETED
sponsor: Takeda
study_type: OBSERVATIONAL
primary_condition: Hypertension
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05107960.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05107960"
ct_last_update_post_date: 2025-09-10
last_seen_at: "2026-05-12T06:09:34.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure

**Official Title:** Special Drug Use Surveillance; AZILVA Tablets and AZILVA Granules 1% in Pediatric Use

**NCT ID:** [NCT05107960](https://clinicaltrials.gov/study/NCT05107960)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 5
- **Lead Sponsor:** Takeda
- **Conditions:** Hypertension
- **Start Date:** 2021-12-16
- **Completion Date:** 2024-08-31
- **CT.gov Last Update:** 2025-09-10

## 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.

## Eligibility

- **Minimum age:** 6 Years
- **Maximum age:** 15 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.

## Interventions

- **Azilsartan (TAK-536)** (DRUG) — Azilsartan Tablets, Azilsartan Granules

## Primary Outcomes

- **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)_
- **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)_

## Locations (1)

- Takeda selected site, Tokyo, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.takeda selected site|tokyo||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05107960.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05107960*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*