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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013618-29 | EudraCT Number | EudraCT |
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To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data
Purpose:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabigatran etexilate | Experimental | treatment with dabigatran oral solution as a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate | Drug | Experimental dose chosen based on age and weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW) | Plasma concentration of total dabigatran (SUM BIBR 953 ZW) | 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 |
| Plasma Concentration of Free Dabigatran (BIBR 953 ZW). | Plasma concentration of free dabigatran (BIBR 953 ZW) | 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 |
| Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS) | 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. | 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 |
| Plasma Concentration of Metabolite BIBR 951 BS | Plasma concentration of metabolite BIBR 951 BS | 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 |
| Plasma Concentration of Metabolite BIBR 1087 SE | Plasma concentration of metabolite BIBR 1087 SE | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Any Adverse Events During the Treatment Period | 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada | |||
| Boehringer Ingelheim Investigational Site |
Open-label, multicentre, non-randomised, uncontrolled, single arm study.
20 patients were enrolled, 18 patients were entered and treated, 2 patients were screening failures.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW) | Plasma concentration of total dabigatran (SUM BIBR 953 ZW) | 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) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 800-243-0127 | +1 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
Not provided
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| Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication. | 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. | at predose and 2 and 10 h after intake of study medication. |
| Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication. | 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 | at predose and 2 and 10 h after intake of study medication. |
| Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication. | 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 | at predose and 2 and 10 h after intake of study medication. |
| Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma) | 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). | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
| Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma) | 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). | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
| 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) | 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). | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
| Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma) | 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). | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
| Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma) | 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). | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
| 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) | 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). | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
| Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period. | 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. | Up to 6 days |
| Up to 6 days |
| Global Assessment of Tolerability of Study Medication- Taste Assessment | 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. | Day 1 (immediately after dosing) |
| Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination | 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. | During the treatment period, Up to 6 days |
| Global Assessment of Tolerability of Study Medication | 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). | Day 1 (immediately after dosing) |
| Roma |
| Italy |
| Boehringer Ingelheim Investigational Site | Vilnius | Lithuania |
| Boehringer Ingelheim Investigational Site | Kazan' | Russia |
| Boehringer Ingelheim Investigational Site | Zurich | Switzerland |
| Boehringer Ingelheim Investigational Site | Bangkok | Thailand |
| Boehringer Ingelheim Investigational Site | Khon Kaen | Thailand |
| 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) |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| OG001 | 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) |
| OG002 | 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) |
|
|
| Primary | Plasma Concentration of Free Dabigatran (BIBR 953 ZW). | Plasma concentration of free dabigatran (BIBR 953 ZW) | PKS (evaluable cases) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
|
| Primary | Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS) | 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. | PKS (evaluable cases) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
|
| Primary | Plasma Concentration of Metabolite BIBR 951 BS | Plasma concentration of metabolite BIBR 951 BS | PKS (evaluable cases) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
|
| Primary | Plasma Concentration of Metabolite BIBR 1087 SE | Plasma concentration of metabolite BIBR 1087 SE | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
|
| Primary | Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication. | 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. | 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. | Posted | Mean | Standard Deviation | seconds | at predose and 2 and 10 h after intake of study medication. |
|
|
|
| Primary | Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication. | 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 | PKS (evaluable cases) | Posted | Mean | Standard Deviation | seconds | at predose and 2 and 10 h after intake of study medication. |
|
|
|
| Primary | Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication. | 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 | PKS (evaluable cases) | Posted | Mean | Standard Deviation | seconds | at predose and 2 and 10 h after intake of study medication. |
|
|
|
| Primary | Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma) | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
|
|
|
| Primary | Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma) | 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). | 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. | Posted | Median | Full Range | hours | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
|
|
|
| Primary | 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) | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
|
|
|
| Primary | Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma) | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
|
|
|
| Primary | Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma) | 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). | 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. | Posted | Median | Full Range | hours | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
|
|
|
| Primary | 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) | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate |
|
|
|
| Primary | Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period. | 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. | Treated set | Posted | Number | Percentage of participants | Up to 6 days |
|
|
|
| Secondary | Percentage of Patients With Any Adverse Events During the Treatment Period | 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. | Treated set | Posted | Number | Percentage of participants | Up to 6 days |
|
|
|
| Secondary | Global Assessment of Tolerability of Study Medication- Taste Assessment | 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. | Treated set | Posted | Number | Percentage of participants | Day 1 (immediately after dosing) |
|
|
|
| Secondary | Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination | 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. | Treated set | Posted | Number | Percentage of participants | During the treatment period, Up to 6 days |
|
|
|
| Secondary | Global Assessment of Tolerability of Study Medication | 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). | Treated set | Posted | Number | Percentage of participants | Day 1 (immediately after dosing) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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) | 0 | 9 | 0 | 9 |
| EG002 | 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) | 0 | 3 | 1 | 3 |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
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
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 2h (N=6, 9, 2) |
|
| 4h (N=6, 9, NA) |
|
| 6h (N=6, 9, NA) |
|
| 10h (N=6, 9, NA) |
|
| 50h (N=NA, NA, 2) |
|
| 72h (N=NA, NA, 3) |
|
| 4h (N=15, NA) |
|
| 6h (N=1, NA) |
|
| 10h (N=15, NA) |
|
| 50h (N=NA, 2) |
|
| 72h (N=NA, 3) |
|
| 4h (N=4, NA) |
|
| 6h (N=15, NA) |
|
| 10h (N=15, NA) |
|
| 50h (N=NA, 2) |
|
| 72h (N=NA, 3) |
|
| 4h (N=1, NA) |
|
| 6h (N=15, NA) |
|
| 10h (N=15, NA) |
|
| 50h (N=NA, 2) |
|
| 72h (N=NA, 3) |
|
| E10 (N=5, 8) |
|
| E10 (N=5, 7) |
|
|
| E10 (N=6, 9, NA) |
|
|
| Satisfactory |
|
| Bad |
|
| Very Bad |
|
| Missing |
|
|
| Not satisfactory |
|
| Bad |
|
| Not assessable |
|