Trial Outcomes & Findings for A Phase 3 Pharmacokinetic Study of TAK-536 (Azilsartan) in Pediatric Patients 6 to Less Than 16 Years With Hypertension (NCT NCT02451150)

NCT ID: NCT02451150

Last Updated: 2016-04-07

Results Overview

AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 6 participants
• Primary outcome timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose
• Results posted on: 2016-04-07

Participant Flow

Participants took part in the study at 3 investigative sites in Japan from 6 August 2015 (first participant signed informed consent) to 10 September 2015.

Participants with a diagnosis of hypertension were enrolled in 1 of 2 treatment groups, TAK-536 (azilsartan) 5 mg or 10 mg based on weight.

Participant milestones

Measure	Azilsartan 5 mg Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 3 Pharmacokinetic Study of TAK-536 (Azilsartan) in Pediatric Patients 6 to Less Than 16 Years With Hypertension

Baseline characteristics by cohort

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.	Total n=6 Participants Total of all reporting groups
Age, Continuous	9.0 years STANDARD_DEVIATION 0.00 • n=5 Participants	13.7 years STANDARD_DEVIATION 0.58 • n=7 Participants	11.3 years STANDARD_DEVIATION 2.58 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Japan	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Height	131.0 cm STANDARD_DEVIATION 10.54 • n=5 Participants	163.3 cm STANDARD_DEVIATION 7.37 • n=7 Participants	147.2 cm STANDARD_DEVIATION 19.49 • n=5 Participants
Weight Categorical <50.0 kg	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Weight Categorical ≥50.0 kg	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Weight	27.53 kg STANDARD_DEVIATION 5.537 • n=5 Participants	65.90 kg STANDARD_DEVIATION 2.955 • n=7 Participants	46.72 kg STANDARD_DEVIATION 21.386 • n=5 Participants
Body Mass Index (BMI)	15.93 kg/m^2 STANDARD_DEVIATION 0.651 • n=5 Participants	24.77 kg/m^2 STANDARD_DEVIATION 2.108 • n=7 Participants	20.35 kg/m^2 STANDARD_DEVIATION 5.035 • n=5 Participants
Caffeine Classification Yes	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Caffeine Classification No	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Disease Duration	0.77 years STANDARD_DEVIATION 0.907 • n=5 Participants	4.17 years STANDARD_DEVIATION 2.994 • n=7 Participants	2.47 years STANDARD_DEVIATION 2.717 • n=5 Participants
Types of Hypertension Essential Hypertension	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Types of Hypertension Secondary Hypertension	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan)	6350.3 ng*hr/mL Standard Deviation 2963.53	6871.7 ng*hr/mL Standard Deviation 893.93

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan)	888.3 ng/mL Standard Deviation 291.11	831.3 ng/mL Standard Deviation 180.79

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan)	6635.7 ng*hr/mL Standard Deviation 3279.58	7433.3 ng*hr/mL Standard Deviation 1227.49

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan)	3.00 hours Interval 2.1 to 3.0	4.00 hours Interval 2.1 to 4.0

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan)	4.727 hours Standard Deviation 1.0083	6.147 hours Standard Deviation 0.67575

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=2 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-I	1592.7 ng*hr/mL Standard Deviation 379.29	1420.5 ng*hr/mL Standard Deviation 707.81

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-I	191.3 ng/mL Standard Deviation 31.39	141.3 ng/mL Standard Deviation 36.50

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=1 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-I	1674.7 ng*hr/mL Standard Deviation 403.91	971.0 ng*hr/mL Standard Deviation NA Cannot be calculated for 1 participant.

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-I	3.00 hours Interval 2.9 to 3.0	6.00 hours Interval 1.0 to 6.0

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=1 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-I	5.437 hours Standard Deviation 0.45938	5.870 hours Standard Deviation NA Cannot be calculated for 1 participant.

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.

Outcome measures

Measure	Azilsartan 5 mg n=2 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=1 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-II	1986.5 ng*hr/mL Standard Deviation 412.24	3526.0 ng*hr/mL Standard Deviation NA Cannot be calculated for 1 participant.

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-II	227.7 ng/mL Standard Deviation 64.38	179.3 ng/mL Standard Deviation 41.50

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.

Outcome measures

Measure	Azilsartan 5 mg n=1 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-II	1798.0 ng*hr/mL Standard Deviation NA Cannot be calculated for 1 participant.	—

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-II	5.90 hours Interval 4.0 to 6.0	8.00 hours Interval 6.0 to 24.1

PRIMARY outcome

Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.

Outcome measures

Measure	Azilsartan 5 mg n=1 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-II	5.510 hours Standard Deviation NA Can not be calculated for 1 participant.	—

PRIMARY outcome

Timeframe: Day 1 from 0 to 24 hours post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 will be calculated from the urinary concentration and volume of each participant.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan)	6.640 percent of dose Standard Deviation 2.9182	5.505 percent of dose Standard Deviation 4.3654

PRIMARY outcome

Timeframe: Day 1 from 0 to 24 hours post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-I will be calculated from the urinary concentration and volume of each participant.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-I	0.1348 percent of dose Standard Deviation 0.20771	0.000 percent of dose Standard Deviation 0.0000

PRIMARY outcome

Timeframe: Day 1 from 0 to 24 hours post-dose

Population: PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.

The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-II will be calculated from the urinary concentration and volume of each participant.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-II	13.53 percent of dose Standard Deviation 2.6839	8.175 percent of dose Standard Deviation 6.4689

PRIMARY outcome

Timeframe: Up to 15 Days

Population: Safety population includes all participants who received at least one dose of study drug.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	1 participants	0 participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline and Day 2

Population: Safety population includes all participants who received at least one dose of study drug.

Vital signs are defined as sitting blood pressure, sitting pulse rate and temperature.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Vital Signs	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline and Day 2

Population: Safety population includes all participants who received at least one dose of study drug.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Body Weight	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline and Day 2

Population: Safety population includes all participants who received at least one dose of study drug.

A resting 12-lead ECG was recorded. The investigator or subinvestigator (or a qualified physician at the study site) interpreted the ECG results.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Resting 12-Lead Electrocardiogram (ECG)	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline and Day 2

Population: Safety population includes all participants who received at least one dose of study drug.

Laboratory test results are defined as serum chemistry, hematology and urinalysis.

Outcome measures

Measure	Azilsartan 5 mg n=3 Participants Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 Participants Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Laboratory Test Results	0 percentage of participants	0 percentage of participants

Adverse Events

Azilsartan 5 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Azilsartan 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Azilsartan 5 mg n=3 participants at risk Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.	Azilsartan 10 mg n=3 participants at risk Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
Infections and infestations Gastroenteritis	33.3% 1/3 • 15 Days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • 15 Days At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director, Clinical Science

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER