Trial Outcomes & Findings for Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age (NCT NCT01083732)
NCT ID: NCT01083732
Last Updated: 2016-12-28
Results Overview
Plasma concentration of total dabigatran (SUM BIBR 953 ZW)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
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
Results posted on
2016-12-28
Participant Flow
20 patients were enrolled, 18 patients were entered and treated, 2 patients were screening failures.
Open-label, multicentre, non-randomised, uncontrolled, single arm study.
Participant milestones
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years):
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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 Study
STARTED
|
6
|
9
|
3
|
|
Overall Study
COMPLETED
|
6
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
Baseline characteristics by cohort
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
1.0 years
STANDARD_DEVIATION 0.0 • n=5 Participants
|
5.2 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
8.3 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
4.3 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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 etexilatePopulation: 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)
Plasma concentration of total dabigatran (SUM BIBR 953 ZW)
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
|---|---|---|---|
|
Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
1h (N= 4, 9, NA)
|
79.4 ng/mL
Geometric Coefficient of Variation 45.6
|
90.6 ng/mL
Geometric Coefficient of Variation 48.8
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
|
Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
2h (N=6, 9, 2)
|
129.0 ng/mL
Geometric Coefficient of Variation 9.84
|
114.0 ng/mL
Geometric Coefficient of Variation 37.9
|
26.0 ng/mL
Geometric Coefficient of Variation 62.6
|
|
Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
4h (N=6, 9, NA)
|
91.0 ng/mL
Geometric Coefficient of Variation 23.0
|
87.7 ng/mL
Geometric Coefficient of Variation 31.6
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
|
Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
6h (N=6, 9, NA)
|
62.9 ng/mL
Geometric Coefficient of Variation 32.6
|
56.2 ng/mL
Geometric Coefficient of Variation 34.2
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
|
Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
10h (N=6, 9, NA)
|
34.8 ng/mL
Geometric Coefficient of Variation 41.4
|
28.2 ng/mL
Geometric Coefficient of Variation 37.0
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
|
Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
50h (N=NA, NA, 2)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
46.0 ng/mL
Geometric Coefficient of Variation 64.7
|
|
Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)
72h (N=NA, NA, 3)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
11.9 ng/mL
Geometric Coefficient of Variation 47.8
|
PRIMARY outcome
Timeframe: 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 etexilatePopulation: PKS (evaluable cases)
Plasma concentration of free dabigatran (BIBR 953 ZW)
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
|---|---|---|---|
|
Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
1h (N= 4, 9, NA)
|
68.5 ng/mL
Geometric Coefficient of Variation 43.8
|
80.0 ng/mL
Geometric Coefficient of Variation 43.9
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
|
Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
2h (N=6, 9, 2)
|
101.0 ng/mL
Geometric Coefficient of Variation 12.8
|
98.5 ng/mL
Geometric Coefficient of Variation 35.3
|
23.4 ng/mL
Geometric Coefficient of Variation 72.2
|
|
Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
4h (N=6, 9, NA)
|
75.3 ng/mL
Geometric Coefficient of Variation 30.2
|
74.5 ng/mL
Geometric Coefficient of Variation 31.7
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
|
Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
6h (N=6, 9, NA)
|
51.6 ng/mL
Geometric Coefficient of Variation 40.0
|
48.4 ng/mL
Geometric Coefficient of Variation 37.9
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
|
Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
10h (N=6, 9, NA)
|
28.1 ng/mL
Geometric Coefficient of Variation 49.8
|
23.7 ng/mL
Geometric Coefficient of Variation 40.3
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
|
Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
50h (N=NA, NA, 2)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
37.3 ng/mL
Geometric Coefficient of Variation 60.7
|
|
Plasma Concentration of Free Dabigatran (BIBR 953 ZW).
72h (N=NA, NA, 3)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
8.43 ng/mL
Geometric Coefficient of Variation 44.0
|
PRIMARY outcome
Timeframe: 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 etexilatePopulation: PKS (evaluable cases)
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.
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=15 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
4h (N=15, NA)
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
50h (N=NA, 2)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
—
|
|
Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
72h (N=NA, 3)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
—
|
|
Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
1h (N= 13, NA)
|
3.82 ng/mL
Geometric Coefficient of Variation 107
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
2h (N=5, 2)
|
3.23 ng/mL
Geometric Coefficient of Variation 74.4
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
—
|
|
Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
6h (N=1, NA)
|
1.05 ng/mL
Geometric Coefficient of Variation NA
All patients except one patient had values below the limit of quantification.
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)
10h (N=15, NA)
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
PRIMARY outcome
Timeframe: 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 etexilatePopulation: PKS (evaluable cases)
Plasma concentration of metabolite BIBR 951 BS
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=15 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Plasma Concentration of Metabolite BIBR 951 BS
1h (N=13, NA)
|
4.88 ng/mL
Geometric Coefficient of Variation 82.2
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Metabolite BIBR 951 BS
2h (N=15, 2)
|
3.55 ng/mL
Geometric Coefficient of Variation 83.0
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
—
|
|
Plasma Concentration of Metabolite BIBR 951 BS
4h (N=4, NA)
|
1.71 ng/mL
Geometric Coefficient of Variation 52.8
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Metabolite BIBR 951 BS
6h (N=15, NA)
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Metabolite BIBR 951 BS
10h (N=15, NA)
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Metabolite BIBR 951 BS
50h (N=NA, 2)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
—
|
|
Plasma Concentration of Metabolite BIBR 951 BS
72h (N=NA, 3)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
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
|
—
|
PRIMARY outcome
Timeframe: 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 etexilatePopulation: 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.
Plasma concentration of metabolite BIBR 1087 SE
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=15 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Plasma Concentration of Metabolite BIBR 1087 SE
10h (N=15, NA)
|
NA ng/mL
Geometric Coefficient of Variation NA
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.
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Metabolite BIBR 1087 SE
1h (N=12, NA)
|
2.31 ng/mL
Geometric Coefficient of Variation 54.0
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Metabolite BIBR 1087 SE
2h (N=8, 2)
|
1.51 ng/mL
Geometric Coefficient of Variation 38.5
|
NA ng/mL
Geometric Coefficient of Variation NA
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.
|
—
|
|
Plasma Concentration of Metabolite BIBR 1087 SE
4h (N=1, NA)
|
1.18 ng/mL
Geometric Coefficient of Variation NA
All patients except one patient had values below the limit of quantification.
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Metabolite BIBR 1087 SE
6h (N=15, NA)
|
NA ng/mL
Geometric Coefficient of Variation NA
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.
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for multiple dose group
|
—
|
|
Plasma Concentration of Metabolite BIBR 1087 SE
50h (N=NA, 2)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
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.
|
—
|
|
Plasma Concentration of Metabolite BIBR 1087 SE
72h (N=NA, 3)
|
NA ng/mL
Geometric Coefficient of Variation NA
Time-point is not applicable for single dose group
|
NA ng/mL
Geometric Coefficient of Variation NA
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.
|
—
|
PRIMARY outcome
Timeframe: at predose and 2 and 10 h after intake of study medication.Population: 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.
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.
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.
Ebase (N=6, 7)
|
32.3 seconds
Standard Deviation 24.6
|
34.9 seconds
Standard Deviation 24.5
|
—
|
|
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.
E2 (N=6, 9)
|
47.5 seconds
Standard Deviation 24.7
|
77.0 seconds
Standard Deviation 54.6
|
—
|
|
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.
E10 (N=5, 8)
|
40.3 seconds
Standard Deviation 19.6
|
58.4 seconds
Standard Deviation 40.6
|
—
|
PRIMARY outcome
Timeframe: at predose and 2 and 10 h after intake of study medication.Population: PKS (evaluable cases)
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
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.
E2 (N=6, 7)
|
79.8 seconds
Standard Deviation 5.15
|
73.6 seconds
Standard Deviation 22.1
|
—
|
|
Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.
E10 (N=5, 7)
|
49.7 seconds
Standard Deviation 5.36
|
52.2 seconds
Standard Deviation 10.3
|
—
|
|
Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.
Ebase (N=6, 6)
|
36.9 seconds
Standard Deviation 7.49
|
36.8 seconds
Standard Deviation 10.5
|
—
|
PRIMARY outcome
Timeframe: at predose and 2 and 10 h after intake of study medication.Population: PKS (evaluable cases)
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
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
|---|---|---|---|
|
Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.
E2 (N=6, 9, 2)
|
46.6 seconds
Standard Deviation 6.02
|
53.6 seconds
Standard Deviation 18.4
|
34.3 seconds
Standard Deviation 1.24
|
|
Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.
E10 (N=6, 9, NA)
|
35.5 seconds
Standard Deviation 6.02
|
39.7 seconds
Standard Deviation 9.76
|
NA seconds
Standard Deviation NA
Time-point is not applicable for multiple dose group
|
|
Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.
Ebase (N=6, 9, 2)
|
31.9 seconds
Standard Deviation 4.67
|
35.6 seconds
Standard Deviation 10.1
|
32.9 seconds
Standard Deviation 4.73
|
PRIMARY outcome
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilatePopulation: 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.
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).
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)
|
129 ng/mL
Geometric Coefficient of Variation 9.84
|
116 ng/mL
Geometric Coefficient of Variation 38.6
|
—
|
PRIMARY outcome
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilatePopulation: 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.
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).
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)
|
1.99 hours
Full Range 9.84 • Interval 1.92 to 2.2
|
2.00 hours
Full Range 38.6 • Interval 1.03 to 4.02
|
—
|
PRIMARY outcome
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilatePopulation: 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.
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).
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
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)
|
715 ng*h/mL
Geometric Coefficient of Variation 22.5
|
658 ng*h/mL
Geometric Coefficient of Variation 32.5
|
—
|
PRIMARY outcome
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilatePopulation: 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.
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).
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)
|
101 ng/mL
Geometric Coefficient of Variation 12.8
|
102 ng/mL
Geometric Coefficient of Variation 36.9
|
—
|
PRIMARY outcome
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilatePopulation: 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.
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).
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)
|
1.99 hours
Full Range 9.84 • Interval 1.92 to 2.2
|
2.00 hours
Full Range 38.6 • Interval 1.08 to 2.08
|
—
|
PRIMARY outcome
Timeframe: At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilatePopulation: 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.
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).
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
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)
|
|---|---|---|---|
|
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)
|
581 ng*h/mL
Geometric Coefficient of Variation 27.7
|
566 ng*h/mL
Geometric Coefficient of Variation 32.2
|
—
|
PRIMARY outcome
Timeframe: Up to 6 daysPopulation: Treated set
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.
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
|---|---|---|---|
|
Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.
|
0.0 Percentage of participants
22.5
|
0.0 Percentage of participants
32.5
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 daysPopulation: Treated set
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.
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
|---|---|---|---|
|
Percentage of Patients With Any Adverse Events During the Treatment Period
|
0.0 Percentage of participants
22.5
|
0.0 Percentage of participants
32.5
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (immediately after dosing)Population: Treated set
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.
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
|---|---|---|---|
|
Global Assessment of Tolerability of Study Medication- Taste Assessment
Very Good
|
0 Percentage of participants
22.5
|
0 Percentage of participants
32.5
|
0 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication- Taste Assessment
Good
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication- Taste Assessment
Satisfactory
|
0 Percentage of participants
|
44.44 Percentage of participants
|
33.33 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication- Taste Assessment
Very Bad
|
0 Percentage of participants
|
33.33 Percentage of participants
|
0 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication- Taste Assessment
Bad
|
0 Percentage of participants
|
0 Percentage of participants
|
66.67 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication- Taste Assessment
Missing
|
100.00 Percentage of participants
|
22.22 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: During the treatment period, Up to 6 daysPopulation: Treated set
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.
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
|---|---|---|---|
|
Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination
|
0.0 Percentage of participants
22.5
|
0.0 Percentage of participants
32.5
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (immediately after dosing)Population: Treated set
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).
Outcome measures
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 Participants
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 Participants
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 Participants
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)
|
|---|---|---|---|
|
Global Assessment of Tolerability of Study Medication
Bad
|
0 Percentage of participants
|
22.22 Percentage of participants
|
0 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication
Good
|
33.33 Percentage of participants
22.5
|
11.11 Percentage of participants
32.5
|
100.00 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication
Satisfactory
|
16.67 Percentage of participants
|
22.22 Percentage of participants
|
0 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication
Not satisfactory
|
33.33 Percentage of participants
|
44.44 Percentage of participants
|
0 Percentage of participants
|
|
Global Assessment of Tolerability of Study Medication
Not assessable
|
16.67 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)
n=6 participants at risk
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)
|
Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)
n=9 participants at risk
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)
|
Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)
n=3 participants at risk
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)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • All adverse events (AEs) during the treatment period, up to 6 days.
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.
|
0.00%
0/9 • All adverse events (AEs) during the treatment period, up to 6 days.
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.
|
33.3%
1/3 • All adverse events (AEs) during the treatment period, up to 6 days.
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All adverse events (AEs) during the treatment period, up to 6 days.
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.
|
0.00%
0/9 • All adverse events (AEs) during the treatment period, up to 6 days.
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.
|
33.3%
1/3 • All adverse events (AEs) during the treatment period, up to 6 days.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER