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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210414 | Registry Identifier | jRCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan (TAK-536) | Drug | Azilsartan Tablets, Azilsartan Granules |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 Months 12 |
| 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 Months 12 |
| Mean Value of Systolic Blood Pressure | Up to 12 Months | |
| Mean Value of Diastolic Blood Pressure | Up to 12 Months | |
| Change From Baseline in Mean Value of Systolic Blood Pressure | Baseline, Up to 12 Months | |
| Change From Baseline in Mean Value of Diastolic Blood Pressure | Baseline, Up to 12 Months |
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Inclusion Criteria
Exclusion Criteria Participants with contraindications to azilsartan.
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Children with hypertension aged 6 years or older and less than 16 years will be included in the survey.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda selected site | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
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Participants with high blood pressure who received azilsartan tablets or granules formulation were enrolled. Participants received azilsartan as part of a routine medical care.
Participants took part in the survey at 3 investigative sites in Japan, from 16 December 2021 to 24 August 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Azilsartan | Participants received azilsartan tablets or granules formulation orally, once daily as part of routine medical care. For children aged 6 years or older, the usual initial oral dosage of azilsartan was 2.5 mg once daily for those weighing <50 kg and 5 mg once daily for those weighing >=50 kg, respectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azilsartan | Participants received azilsartan tablets or granules formulation orally, once daily as part of routine medical care. For children aged 6 years or older, the usual initial oral dosage of azilsartan was 2.5 mg once daily for those weighing <50 kg and 5 mg once daily for those weighing >=50 kg, respectively. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to Months 12 |
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Up to 12 Months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azilsartan | Participants received azilsartan tablets or granules formulation orally, once daily as part of routine medical care. For children aged 6 years or older, the usual initial oral dosage of azilsartan was 2.5 mg once daily for those weighing <50 kg and 5 mg once daily for those weighing >=50 kg, respectively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2024 | Sep 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2024 | Sep 8, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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Participants received azilsartan tablets or granules formulation orally, once daily as part of routine medical care. For children aged 6 years or older, the usual initial oral dosage of azilsartan was 2.5 mg once daily for those weighing <50 kg and 5 mg once daily for those weighing >=50 kg, respectively.
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| 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Up to Months 12 |
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| Primary | Mean Value of Systolic Blood Pressure | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Up to 12 Months |
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| Primary | Mean Value of Diastolic Blood Pressure | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Up to 12 Months |
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| Primary | Change From Baseline in Mean Value of Systolic Blood Pressure | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, Up to 12 Months |
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| Primary | Change From Baseline in Mean Value of Diastolic Blood Pressure | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, Up to 12 Months |
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