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Trial record 48 of 333 for:    DABIGATRAN

Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01083732
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : December 28, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Venous Thromboembolism
Intervention Drug: dabigatran etexilate
Enrollment 18
Recruitment Details 20 patients were enrolled, 18 patients were entered and treated, 2 patients were screening failures.
Pre-assignment Details Open-label, multicentre, non-randomised, uncontrolled, single arm study.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years): Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Period Title: Overall Study
Started 6 9 3
Completed 6 9 3
Not Completed 0 0 0
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years) Total
Hide Arm/Group Description The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) Total of all reporting groups
Overall Number of Baseline Participants 6 9 3 18
Hide Baseline Analysis Population Description
Treated set (TS): This patient set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 9 participants 3 participants 18 participants
1.0  (0.0) 5.2  (2.6) 8.3  (2.5) 4.3  (3.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 3 participants 18 participants
Female
2
  33.3%
3
  33.3%
2
  66.7%
7
  38.9%
Male
4
  66.7%
6
  66.7%
1
  33.3%
11
  61.1%
1.Primary Outcome
Title Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
Hide Description Plasma concentration of total dabigatran (SUM BIBR 953 ZW)
Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
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Hide Analysis Population Description

Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.

PKS (evaluable cases)

Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1h (N= 4, 9, NA)
79.4
(45.6%)
90.6
(48.8%)
NA [1] 
(NA%)
2h (N=6, 9, 2)
129.0
(9.84%)
114.0
(37.9%)
26.0
(62.6%)
4h (N=6, 9, NA)
91.0
(23.0%)
87.7
(31.6%)
NA [1] 
(NA%)
6h (N=6, 9, NA)
62.9
(32.6%)
56.2
(34.2%)
NA [1] 
(NA%)
10h (N=6, 9, NA)
34.8
(41.4%)
28.2
(37.0%)
NA [1] 
(NA%)
50h (N=NA, NA, 2)
NA [2] 
(NA%)
NA [2] 
(NA%)
46.0
(64.7%)
72h (N=NA, NA, 3)
NA [2] 
(NA%)
NA [2] 
(NA%)
11.9
(47.8%)
[1]
Time-point is not applicable for multiple dose group
[2]
Time-point is not applicable for single dose group
2.Primary Outcome
Title Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
Hide Description Plasma concentration of free dabigatran (BIBR 953 ZW)
Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
Hide Outcome Measure Data
Hide Analysis Population Description
PKS (evaluable cases)
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1h (N= 4, 9, NA)
68.5
(43.8%)
80.0
(43.9%)
NA [1] 
(NA%)
2h (N=6, 9, 2)
101.0
(12.8%)
98.5
(35.3%)
23.4
(72.2%)
4h (N=6, 9, NA)
75.3
(30.2%)
74.5
(31.7%)
NA [1] 
(NA%)
6h (N=6, 9, NA)
51.6
(40.0%)
48.4
(37.9%)
NA [1] 
(NA%)
10h (N=6, 9, NA)
28.1
(49.8%)
23.7
(40.3%)
NA [1] 
(NA%)
50h (N=NA, NA, 2)
NA [2] 
(NA%)
NA [2] 
(NA%)
37.3
(60.7%)
72h (N=NA, NA, 3)
NA [2] 
(NA%)
NA [2] 
(NA%)
8.43
(44.0%)
[1]
Time-point is not applicable for multiple dose group
[2]
Time-point is not applicable for single dose group
3.Primary Outcome
Title Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
Hide Description

Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).

Some values are "NA" because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules.

Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
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Hide Analysis Population Description
PKS (evaluable cases)
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 15 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1h (N= 13, NA)
3.82
(107%)
NA [1] 
(NA%)
2h (N=5, 2)
3.23
(74.4%)
NA [2] 
(NA%)
4h (N=15, NA)
NA [2] 
(NA%)
NA [1] 
(NA%)
6h (N=1, NA)
1.05 [3] 
(NA%)
NA [1] 
(NA%)
10h (N=15, NA)
NA [2] 
(NA%)
NA [1] 
(NA%)
50h (N=NA, 2)
NA [4] 
(NA%)
NA [2] 
(NA%)
72h (N=NA, 3)
NA [4] 
(NA%)
NA [2] 
(NA%)
[1]
Time-point is not applicable for multiple dose group
[2]
Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules
[3]
All patients except one patient had values below the limit of quantification.
[4]
Time-point is not applicable for single dose group
4.Primary Outcome
Title Plasma Concentration of Metabolite BIBR 951 BS
Hide Description Plasma concentration of metabolite BIBR 951 BS
Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
Hide Outcome Measure Data
Hide Analysis Population Description
PKS (evaluable cases)
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 15 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1h (N=13, NA)
4.88
(82.2%)
NA [1] 
(NA%)
2h (N=15, 2)
3.55
(83.0%)
NA [2] 
(NA%)
4h (N=4, NA)
1.71
(52.8%)
NA [1] 
(NA%)
6h (N=15, NA)
NA [2] 
(NA%)
NA [1] 
(NA%)
10h (N=15, NA)
NA [2] 
(NA%)
NA [1] 
(NA%)
50h (N=NA, 2)
NA [3] 
(NA%)
NA [2] 
(NA%)
72h (N=NA, 3)
NA [3] 
(NA%)
NA [2] 
(NA%)
[1]
Time-point is not applicable for multiple dose group
[2]
Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules
[3]
Time-point is not applicable for single dose group
5.Primary Outcome
Title Plasma Concentration of Metabolite BIBR 1087 SE
Hide Description Plasma concentration of metabolite BIBR 1087 SE
Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 15 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1h (N=12, NA)
2.31
(54.0%)
NA [1] 
(NA%)
2h (N=8, 2)
1.51
(38.5%)
NA [2] 
(NA%)
4h (N=1, NA)
1.18 [3] 
(NA%)
NA [1] 
(NA%)
6h (N=15, NA)
NA [2] 
(NA%)
NA [1] 
(NA%)
10h (N=15, NA)
NA [2] 
(NA%)
NA [1] 
(NA%)
50h (N=NA, 2)
NA [4] 
(NA%)
NA [2] 
(NA%)
72h (N=NA, 3)
NA [4] 
(NA%)
NA [2] 
(NA%)
[1]
Time-point is not applicable for multiple dose group
[2]
Values below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.
[3]
All patients except one patient had values below the limit of quantification.
[4]
Time-point is not applicable for single dose group
6.Primary Outcome
Title Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.
Hide Description Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation.
Time Frame at predose and 2 and 10 h after intake of study medication.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9
Mean (Standard Deviation)
Unit of Measure: seconds
Ebase (N=6, 7) 32.3  (24.6) 34.9  (24.5)
E2 (N=6, 9) 47.5  (24.7) 77.0  (54.6)
E10 (N=5, 8) 40.3  (19.6) 58.4  (40.6)
7.Primary Outcome
Title Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.
Hide Description Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation
Time Frame at predose and 2 and 10 h after intake of study medication.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS (evaluable cases)
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9
Mean (Standard Deviation)
Unit of Measure: seconds
Ebase (N=6, 6) 36.9  (7.49) 36.8  (10.5)
E2 (N=6, 7) 79.8  (5.15) 73.6  (22.1)
E10 (N=5, 7) 49.7  (5.36) 52.2  (10.3)
8.Primary Outcome
Title Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.
Hide Description Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation
Time Frame at predose and 2 and 10 h after intake of study medication.
Hide Outcome Measure Data
Hide Analysis Population Description
PKS (evaluable cases)
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9 3
Mean (Standard Deviation)
Unit of Measure: seconds
Ebase (N=6, 9, 2) 31.9  (4.67) 35.6  (10.1) 32.9  (4.73)
E2 (N=6, 9, 2) 46.6  (6.02) 53.6  (18.4) 34.3  (1.24)
E10 (N=6, 9, NA) 35.5  (6.02) 39.7  (9.76) NA [1]   (NA)
[1]
Time-point is not applicable for multiple dose group
9.Primary Outcome
Title Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)
Hide Description Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).
Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
129
(9.84%)
116
(38.6%)
10.Primary Outcome
Title Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)
Hide Description

tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).

Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation).
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9
Median (Full Range)
Unit of Measure: hours
1.99
(1.92 to 2.20)
2.00
(1.03 to 4.02)
11.Primary Outcome
Title AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)
Hide Description

AUC0-tz (area under the concentration time curve of the total dabigatran in plasma over the time interval 0 up to the last quantifiable data point).

Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
715
(22.5%)
658
(32.5%)
12.Primary Outcome
Title Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)
Hide Description Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).
Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
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The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
101
(12.8%)
102
(36.9%)
13.Primary Outcome
Title Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)
Hide Description

tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).

Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
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Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9
Median (Full Range)
Unit of Measure: hours
1.99
(1.92 to 2.20)
2.00
(1.08 to 2.08)
14.Primary Outcome
Title AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)
Hide Description

AUC0-tz (area under the concentration time curve of the free dabigatran in plasma over the time interval 0 up to the last quantifiable data point).

Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).

Time Frame At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate
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Hide Analysis Population Description
Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
581
(27.7%)
566
(32.2%)
15.Primary Outcome
Title Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.
Hide Description Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered & which was not directly attributable to the patient’s underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.
Time Frame Up to 6 days
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Treated set
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9 3
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0 0.0
16.Secondary Outcome
Title Percentage of Patients With Any Adverse Events During the Treatment Period
Hide Description Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.
Time Frame Up to 6 days
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Treated set
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9 3
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0 33.3
17.Secondary Outcome
Title Global Assessment of Tolerability of Study Medication- Taste Assessment
Hide Description The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste.
Time Frame Day 1 (immediately after dosing)
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Treated set
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9 3
Measure Type: Number
Unit of Measure: Percentage of participants
Very Good 0 0 0
Good 0 0 0
Satisfactory 0 44.44 33.33
Bad 0 0 66.67
Very Bad 0 33.33 0
Missing 100.00 22.22 0
18.Secondary Outcome
Title Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination
Hide Description

Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.

Clinically Relevant Abnormalities for Laboratory Parameters were reported.

Time Frame During the treatment period, Up to 6 days
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Treated set
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9 3
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.0 0.0
19.Secondary Outcome
Title Global Assessment of Tolerability of Study Medication
Hide Description The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).
Time Frame Day 1 (immediately after dosing)
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Treated set
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description:
The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
Overall Number of Participants Analyzed 6 9 3
Measure Type: Number
Unit of Measure: Percentage of participants
Good 33.33 11.11 100.00
Satisfactory 16.67 22.22 0
Not satisfactory 33.33 44.44 0
Bad 0 22.22 0
Not assessable 16.67 0 0
Time Frame All adverse events (AEs) during the treatment period, up to 6 days.
Adverse Event Reporting Description For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.
 
Arm/Group Title Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Hide Arm/Group Description The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation) The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
All-Cause Mortality
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/9 (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%
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years) Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years) Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/9 (0.00%)   1/3 (33.33%) 
Blood and lymphatic system disorders       
Leukopenia  1  0/6 (0.00%)  0/9 (0.00%)  1/3 (33.33%) 
Nervous system disorders       
Dizziness  1  0/6 (0.00%)  0/9 (0.00%)  1/3 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 800-243-0127 ext +1
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01083732     History of Changes
Other Study ID Numbers: 1160.89
2009-013618-29 ( EudraCT Number: EudraCT )
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: August 17, 2016
Results First Posted: December 28, 2016
Last Update Posted: December 28, 2016