Trial Outcomes & Findings for A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure (NCT NCT05107960)

NCT ID: NCT05107960

Last Updated: 2025-09-10

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 5 participants
• Primary outcome timeframe: Up to Months 12
• Results posted on: 2025-09-10

Participant Flow

Participants took part in the survey at 3 investigative sites in Japan, from 16 December 2021 to 24 August 2024.

Participants with high blood pressure who received azilsartan tablets or granules formulation were enrolled. Participants received azilsartan as part of a routine medical care.

Participant milestones

Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Azilsartan n=5 Participants 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.
Age, Continuous	11.4 years STANDARD_DEVIATION 1.52 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Months 12

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

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.

Outcome measures

Measure	Azilsartan n=5 Participants 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.
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)	0 Participants

PRIMARY outcome

Timeframe: Up to Months 12

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

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.

Outcome measures

Measure	Azilsartan n=5 Participants 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.
Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Azilsartan n=5 Participants 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.
Mean Value of Systolic Blood Pressure Baseline	121.8 mmHg Standard Deviation 10.47
Mean Value of Systolic Blood Pressure Month 1	109.8 mmHg Standard Deviation 17.90
Mean Value of Systolic Blood Pressure Month 2	112.3 mmHg Standard Deviation 24.01
Mean Value of Systolic Blood Pressure Month 3	117.5 mmHg Standard Deviation 20.51
Mean Value of Systolic Blood Pressure Month 4	113.3 mmHg Standard Deviation 6.90
Mean Value of Systolic Blood Pressure Month 5	115.5 mmHg Standard Deviation 3.54
Mean Value of Systolic Blood Pressure Month 6	97.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Mean Value of Systolic Blood Pressure Month 7	116.5 mmHg Standard Deviation 13.44
Mean Value of Systolic Blood Pressure Month 8	116.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Mean Value of Systolic Blood Pressure Month 9	102.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Mean Value of Systolic Blood Pressure Month 11	108.5 mmHg Standard Deviation 12.02

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Azilsartan n=5 Participants 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.
Mean Value of Diastolic Blood Pressure Baseline	72.8 mmHg Standard Deviation 10.31
Mean Value of Diastolic Blood Pressure Month 1	65.8 mmHg Standard Deviation 9.78
Mean Value of Diastolic Blood Pressure Month 2	68.0 mmHg Standard Deviation 12.00
Mean Value of Diastolic Blood Pressure Month 3	77.5 mmHg Standard Deviation 3.54
Mean Value of Diastolic Blood Pressure Month 4	64.0 mmHg Standard Deviation 8.76
Mean Value of Diastolic Blood Pressure Month 5	58.5 mmHg Standard Deviation 0.71
Mean Value of Diastolic Blood Pressure Month 6	61.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Mean Value of Diastolic Blood Pressure Month 7	57.0 mmHg Standard Deviation 11.31
Mean Value of Diastolic Blood Pressure Month 8	66.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Mean Value of Diastolic Blood Pressure Month 9	51.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Mean Value of Diastolic Blood Pressure Month 11	57.0 mmHg Standard Deviation 0.00

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Azilsartan n=5 Participants 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.
Change From Baseline in Mean Value of Systolic Blood Pressure Month 1	-8.5 mmHg Standard Deviation 24.80
Change From Baseline in Mean Value of Systolic Blood Pressure Month 2	-14.7 mmHg Standard Deviation 30.01
Change From Baseline in Mean Value of Systolic Blood Pressure Month 3	2.5 mmHg Standard Deviation 20.51
Change From Baseline in Mean Value of Systolic Blood Pressure Month 4	-5.0 mmHg Standard Deviation 14.45
Change From Baseline in Mean Value of Systolic Blood Pressure Month 5	-10.0 mmHg Standard Deviation 11.31
Change From Baseline in Mean Value of Systolic Blood Pressure Month 6	-33.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Change From Baseline in Mean Value of Systolic Blood Pressure Month 7	-9.0 mmHg Standard Deviation 1.41
Change From Baseline in Mean Value of Systolic Blood Pressure Month 8	-14.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Change From Baseline in Mean Value of Systolic Blood Pressure Month 9	-34.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Change From Baseline in Mean Value of Systolic Blood Pressure Month 11	-24.5 mmHg Standard Deviation 7.78

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Azilsartan n=5 Participants 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.
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 1	-9.0 mmHg Standard Deviation 14.90
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 2	-3.3 mmHg Standard Deviation 23.16
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 3	12.0 mmHg Standard Deviation 1.41
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 4	-10.8 mmHg Standard Deviation 13.89
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 5	-6.0 mmHg Standard Deviation 1.41
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 6	-24.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 7	-7.5 mmHg Standard Deviation 10.61
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 8	-19.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 9	-14.0 mmHg Standard Deviation NA The standard deviation was not evaluable due to low number of participants with events.
Change From Baseline in Mean Value of Diastolic Blood Pressure Month 11	-18.0 mmHg Standard Deviation 14.14

Adverse Events

Azilsartan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place