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A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01078376
Recruitment Status : Terminated (Business Decision (see below))
First Posted : March 2, 2010
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Hypertension
Intervention Drug: Azilsartan medoxomil (TAK-491)
Enrollment 29
Recruitment Details Participants took part in the study at 6 sites in the United States and 3 sites in the United Kingdom from 10 May 2010 to 10 July 2013.
Pre-assignment Details Children between the ages of 1 to 16 years (including up to their 17th birthday) with hypertension and gender-matched healthy adults aged 18 to 45 years, inclusive, were enrolled in 1 of 3 cohorts.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description Azilsartan medoxomil 80 mg, tablets, orally, one day only Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose. Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose. Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Period Title: Overall Study
Started 9 9 8 3
Completed 9 9 8 3
Not Completed 0 0 0 0
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg Cohort 3: Children (≥1 to <6 Years Old) Total
Hide Arm/Group Description Azilsartan medoxomil 80 mg, tablets, orally, one day only Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose. Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose. Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only Total of all reporting groups
Overall Number of Baseline Participants 9 9 8 3 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 8 participants 3 participants 29 participants
28.3  (7.78) 14.2  (1.64) 9.1  (2.10) 4.7  (0.58) 16.2  (9.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 8 participants 3 participants 29 participants
Female
2
  22.2%
2
  22.2%
5
  62.5%
2
  66.7%
11
  37.9%
Male
7
  77.8%
7
  77.8%
3
  37.5%
1
  33.3%
18
  62.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 8 participants 3 participants 29 participants
Hispanic or Latino 4 0 1 0 5
Not Hispanic or Latino 5 7 5 3 20
Not Reported 0 2 2 0 4
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 8 participants 3 participants 29 participants
Asian 0 0 1 0 1
Black or African American 1 2 2 2 7
White 8 7 5 1 21
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 9 participants 9 participants 8 participants 3 participants 29 participants
172.6  (9.70) 163.1  (11.72) 138.6  (12.74) 107.7  (11.06) 153.6  (23.45)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 9 participants 9 participants 8 participants 3 participants 29 participants
74.64  (11.207) 71.71  (15.512) 48.50  (22.523) 18.30  (4.026) 60.69  (23.859)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 9 participants 9 participants 8 participants 3 participants 29 participants
25.06  (3.345) 27.22  (6.611) 24.29  (8.327) 15.67  (0.551) 24.54  (6.625)
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536
Hide Description AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: ng.hr/mL
40613  (9609.6) 23889  (5383.8) 17423  (3559.7) 16056 [1]   (NA) 22556  (5792.6) 18691  (5489.9) 16963  (4948.4)
[1]
Standard deviation can not be calculated for 1 participant.
2.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 Metabolite M-II.
Hide Description AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: ng.hr/mL
11563  (3106.5) 7409  (78.6) 7428  (2120.7) 7392 [1]   (NA) 7929  (3502.6) 9130  (1338.3) 7285  (3626.0)
[1]
Standard deviation can not be calculated for 1 participant.
3.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536
Hide Description Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: ng.hr/mL
44820  (11680.7) 26411  (6703.1) 18686  (3720.4) 16563 [1]   (NA) 23792  (6157.0) 19543  (6181.1) 17771  (5263.1)
[1]
Standard deviation can not be calculated for 1 participant.
4.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536 Metabolite M-II
Hide Description Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: ng.hr/mL
19188  (6766.0) 10596  (1168.8) 12532  (3905.3) 8961 [1]   (NA) 11387  (5440.7) 14230  (3419.6) 9477  (4659.6)
[1]
Standard deviation can not be calculated for 1 participant.
5.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) for TAK-536
Hide Description Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
5699  (1346.1) 3245  (106.1) 2512  (701.6) 2810 [1]   (NA) 3858  (1363.0) 2960  (364.3) 3320  (656.0)
[1]
Standard deviation can not be calculated for 1 participant.
6.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) for TAK-536 Metabolite M-II
Hide Description Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
736  (241.6) 480  (74.2) 535  (200.2) 514 [1]   (NA) 561  (211.7) 561  (40.3) 488  (212.2)
[1]
Standard deviation can not be calculated for 1 participant.
7.Primary Outcome
Title Time to Reach Cmax (Tmax) for TAK-536
Hide Description Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Median (Full Range)
Unit of Measure: hr
2.00
(2.00 to 4.00)
2.01
(2.00 to 2.02)
2.00
(1.00 to 2.00)
2.00 [1] 
(NA to NA)
2.00
(1.05 to 6.00)
2.00
(1.98 to 2.00)
1.00
(1.00 to 1.00)
[1]
Standard deviation or range cannot be calculated for 1 participant.
8.Primary Outcome
Title Time to Reach Cmax (Tmax) for TAK-536 Metabolite M-II
Hide Description Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Median (Full Range)
Unit of Measure: hr
6.00
(4.00 to 8.00)
5.00
(4.00 to 6.00)
6.00
(4.00 to 6.10)
6.00 [1] 
(NA to NA)
4.03
(4.00 to 8.00)
4.00
(4.00 to 8.00)
6.0
(6.00 to 6.00)
[1]
Standard deviation or range cannot be calculated for 1 participant.
9.Primary Outcome
Title Terminal Elimination Half-life (T1/2) for TAK-536
Hide Description Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: hr
7.35  (1.083) 7.74  (0.621) 5.76  (1.158) 5.07 [1]   (NA) 5.75  (0.760) 5.37  (0.922) 4.59  (1.627)
[1]
Standard deviation can not be calculated for 1 participant.
10.Primary Outcome
Title Terminal Elimination Half-life (T1/2) for TAK-536 Metabolite M-II
Hide Description Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: hr
16.60  (6.870) 12.78  (2.915) 14.00  (2.414) 8.50 [1]   (NA) 11.56  (3.314) 13.97  (2.983) 10.35  (2.770)
[1]
Standard deviation can not be calculated for 1 participant.
11.Primary Outcome
Title Apparent Oral Clearance (CL/F) for TAK-536
Hide Description CL/F is apparent clearance of the drug from the plasma, expressed in L/hr.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3 3
Mean (Standard Deviation)
Unit of Measure: L/hr
1.52  (0.414) 1.88  (0.477) 1.78  (0.411) 2.90 [1]   (NA) 1.43  (0.427) 0.87  (0.232) 0.54  (0.134)
[1]
Standard deviation can not be calculated for 1 participant.
12.Primary Outcome
Title Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Hide Description [Not Specified]
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Overall Number of Participants Analyzed 9 3 6 1 4 3
Mean (Standard Deviation)
Unit of Measure: mg
10.65  (4.673) 4.56  (1.029) 2.89  (0.936) 4.59 [1]   (NA) 3.63  (2.125) 1.27  (0.580)
[1]
Standard deviation can not be calculated for 1 participant.
13.Primary Outcome
Title Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Hide Description [Not Specified]
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Overall Number of Participants Analyzed 9 3 6 1 4 3
Mean (Standard Deviation)
Unit of Measure: mg
6.60  (5.149) 2.93  (0.582) 2.73  (1.528) 4.43 [1]   (NA) 2.77  (1.197) 1.48  (0.284)
[1]
Standard deviation can not be calculated for 1 participant.
14.Primary Outcome
Title Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Hide Description Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Overall Number of Participants Analyzed 9 3 6 1 4 3
Mean (Standard Deviation)
Unit of Measure: percent
16.65  (7.302) 9.50  (2.144) 9.04  (2.925) 9.57 [1]   (NA) 11.36  (6.639) 7.94  (3.622)
[1]
Standard deviation can not be calculated for 1 participant.
15.Primary Outcome
Title Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Hide Description Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Overall Number of Participants Analyzed 9 3 6 1 4 3
Mean (Standard Deviation)
Unit of Measure: percent
11.01  (8.581) 6.55  (1.293) 9.11  (5.094) 9.85 [1]   (NA) 9.22  (3.991) 9.89  (1.896)
[1]
Standard deviation can not be calculated for 1 participant.
16.Primary Outcome
Title Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Hide Description Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3
Mean (Standard Deviation)
Unit of Measure: L/hr
0.28  (0.130) 0.22  (0.051) 0.17  (0.077) 0.29 [1]   (NA) 0.15  (0.069) 0.07  (0.011)
[1]
Standard deviation can not be calculated for 1 participant.
17.Primary Outcome
Title Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Hide Description Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 60 mg Cohort 2: Children (≥6 to <12 Years Old) 40 mg Cohort 2: Children (≥6 to <12 Years Old) 20 mg
Hide Arm/Group Description:
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 60 mg, tablets, orally, one day only
Azilsartan medoxomil 40 mg, tablets, orally, one day only
Azilsartan medoxomil 20 mg, tablets, orally, one day only
Overall Number of Participants Analyzed 9 2 6 1 4 3
Mean (Standard Deviation)
Unit of Measure: L/hr
0.55  (0.309) 0.37  (0.084) 0.34  (0.146) 0.60 [1]   (NA) 0.36  (0.099) 0.16  (0.022)
[1]
Standard deviation can not be calculated for 1 participant.
Time Frame A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
Adverse Event Reporting Description At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg Cohort 3: Children (≥1 to <6 Years Old)
Hide Arm/Group Description Azilsartan medoxomil 80 mg, tablets, orally, one day only Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose. Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose. Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
All-Cause Mortality
Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg Cohort 3: Children (≥1 to <6 Years Old)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg Cohort 3: Children (≥1 to <6 Years Old)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/8 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Healthy Adults Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg Cohort 3: Children (≥1 to <6 Years Old)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/9 (22.22%)   5/9 (55.56%)   3/8 (37.50%)   0/3 (0.00%) 
Cardiac disorders         
Sinus bradycardia  1  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort  1  0/9 (0.00%)  2/9 (22.22%)  0/8 (0.00%)  0/3 (0.00%) 
General disorders         
Infusion site pain  1  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/3 (0.00%) 
Infections and infestations         
Infected bites  1  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%)  0/3 (0.00%) 
Sinusitis  1  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/3 (0.00%) 
Nervous system disorders         
Headache  1  0/9 (0.00%)  2/9 (22.22%)  1/8 (12.50%)  0/3 (0.00%) 
Dizziness  1  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/3 (0.00%) 
Migraine  1  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/3 (0.00%) 
Vascular disorders         
Haematoma  1  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
The study was discontinued without complete enrollment of Cohort 3. Therefore, PK modeling will be used to determine the appropriate doses in children 1 to <6 years of age, in lieu of completing Cohort 3.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No publication related to study results will be made without Sponsor’s prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01078376     History of Changes
Other Study ID Numbers: TAK-491_109
2009-013165-25 ( EudraCT Number )
U1111-1113-4416 ( Registry Identifier: WHO )
First Submitted: February 26, 2010
First Posted: March 2, 2010
Results First Submitted: June 26, 2014
Results First Posted: July 25, 2014
Last Update Posted: July 25, 2014