Hypertension
Conditions
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.
Interventions
DRUGAzilsartan (TAK-536)
Azilsartan Tablets, Azilsartan Granules
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 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) | 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 | 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 | — |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 3 investigative sites in Japan, from 16 December 2021 to 24 August 2024.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Azilsartan | — |
|---|---|---|
| Age, Continuous | 11.4 years STANDARD_DEVIATION 1.52 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change From Baseline in Mean Value of Diastolic Blood Pressure
Time frame: Baseline, Up to 12 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 7 | -7.5 mmHg | Standard Deviation 10.61 |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 9 | -14.0 mmHg | — |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 1 | -9.0 mmHg | Standard Deviation 14.9 |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 2 | -3.3 mmHg | Standard Deviation 23.16 |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 3 | 12.0 mmHg | Standard Deviation 1.41 |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 4 | -10.8 mmHg | Standard Deviation 13.89 |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 5 | -6.0 mmHg | Standard Deviation 1.41 |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 6 | -24.0 mmHg | — |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 8 | -19.0 mmHg | — |
| Azilsartan | Change From Baseline in Mean Value of Diastolic Blood Pressure | Month 11 | -18.0 mmHg | Standard Deviation 14.14 |
Primary
Change From Baseline in Mean Value of Systolic Blood Pressure
Time frame: Baseline, Up to 12 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 7 | -9.0 mmHg | Standard Deviation 1.41 |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 1 | -8.5 mmHg | Standard Deviation 24.8 |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 2 | -14.7 mmHg | Standard Deviation 30.01 |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 3 | 2.5 mmHg | Standard Deviation 20.51 |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 4 | -5.0 mmHg | Standard Deviation 14.45 |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 5 | -10.0 mmHg | Standard Deviation 11.31 |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 6 | -33.0 mmHg | — |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 8 | -14.0 mmHg | — |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 9 | -34.0 mmHg | — |
| Azilsartan | Change From Baseline in Mean Value of Systolic Blood Pressure | Month 11 | -24.5 mmHg | Standard Deviation 7.78 |
Primary
Mean Value of Diastolic Blood Pressure
Time frame: Up to 12 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 7 | 57.0 mmHg | Standard Deviation 11.31 |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Baseline | 72.8 mmHg | Standard Deviation 10.31 |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 1 | 65.8 mmHg | Standard Deviation 9.78 |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 2 | 68.0 mmHg | Standard Deviation 12 |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 3 | 77.5 mmHg | Standard Deviation 3.54 |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 4 | 64.0 mmHg | Standard Deviation 8.76 |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 5 | 58.5 mmHg | Standard Deviation 0.71 |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 6 | 61.0 mmHg | — |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 8 | 66.0 mmHg | — |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 9 | 51.0 mmHg | — |
| Azilsartan | Mean Value of Diastolic Blood Pressure | Month 11 | 57.0 mmHg | Standard Deviation 0 |
Primary
Mean Value of Systolic Blood Pressure
Time frame: Up to 12 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 9 | 102.0 mmHg | — |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 11 | 108.5 mmHg | Standard Deviation 12.02 |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 8 | 116.0 mmHg | — |
| Azilsartan | Mean Value of Systolic Blood Pressure | Baseline | 121.8 mmHg | Standard Deviation 10.47 |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 1 | 109.8 mmHg | Standard Deviation 17.9 |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 2 | 112.3 mmHg | Standard Deviation 24.01 |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 3 | 117.5 mmHg | Standard Deviation 20.51 |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 4 | 113.3 mmHg | Standard Deviation 6.9 |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 5 | 115.5 mmHg | Standard Deviation 3.54 |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 6 | 97.0 mmHg | — |
| Azilsartan | Mean Value of Systolic Blood Pressure | Month 7 | 116.5 mmHg | Standard Deviation 13.44 |
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.
Time frame: Up to Months 12
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Azilsartan | Number of Participants Who Experienced at Least One Serious Adverse Event (SAE) | 0 Participants |
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.
Time frame: Up to Months 12
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Azilsartan | Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 0 Participants |