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To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabigatran etexilate | Experimental | open label; patient to receive dabigatran etexilate BID for three days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate | Drug | 2.14 mg/kg BID to a max 150 mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Bleeding Events (Major and Minor) | Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria: Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. | From Screening until 30 days after first drug administration (end of trial visit) |
| Number of Patients With Adverse Events | Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration. | From Screening until 30 days after first drug administration (end of trial visit) |
| Plasma Concentration of Free Dabigatran | Plasma concentration of free dabigatran measured at 72 hours after first dose | 3 days |
| Plasma Concentration of Total Dabigatran | Plasma concentration of total dabigatran measured at 72 hours after first dose | Day 3 |
| Thrombin Time (TT) Centrally Measured | Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay. | Day 3 |
| TT Locally Measured |
| Measure | Description | Time Frame |
|---|---|---|
| Activated Partial Thromboplastin Time (aPTT) Centrally Measured | Measurement of aPTT was performed locally and centrally using validated assays. | Day 3 |
| aPTT Locally Measured | Measurement of aPTT was performed locally and centrally using validated assays. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.88.00002 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada | |||
| 1160.88.00001 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27357738 | Derived | Halton JM, Lehr T, Cronin L, Lobmeyer MT, Haertter S, Belletrutti M, Mitchell LG. Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study. Thromb Haemost. 2016 Aug 30;116(3):461-71. doi: 10.1160/TH15-04-0275. Epub 2016 Jun 30. |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients (Pat.) | Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg). |
| 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 | Number of Patients With Bleeding Events (Major and Minor) | Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria: Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. | Treated set (TS). This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. | Posted | Number | Participants | From Screening until 30 days after first drug administration (end of trial visit) |
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay. |
| Day 3 |
| Day 3 |
| Ecarin Clotting Time (ECT) | Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT. | Day 3 |
| Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs | Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator. | Baseline and 3 days |
| Occurences of Clinical Outcome | Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported. | 3 days |
| Ottawa |
| Ontario |
| Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg). |
|
|
| Primary | Number of Patients With Adverse Events | Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered "on-treatment" if occurring within 72 hours after last drug administration. | TS | Posted | Number | Participants | From Screening until 30 days after first drug administration (end of trial visit) |
|
|
|
| Primary | Plasma Concentration of Free Dabigatran | Plasma concentration of free dabigatran measured at 72 hours after first dose | Treated Set. Descriptive statistics for the concentration measurement could only be calculated for the subgroups of patients receiving the same sequence of doses. Statistics were only reported for groups with at least 3 patients (non-sparse data). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | 3 days |
|
|
|
| Primary | Plasma Concentration of Total Dabigatran | Plasma concentration of total dabigatran measured at 72 hours after first dose | TS with non-sparse data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | Day 3 |
|
|
|
| Primary | Thrombin Time (TT) Centrally Measured | Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay. | TS with non-sparse data | Posted | Mean | Standard Deviation | seconds | Day 3 |
|
|
|
| Primary | TT Locally Measured | Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay. | TS with non-sparse data | Posted | Mean | Standard Deviation | seconds | Day 3 |
|
|
|
| Secondary | Activated Partial Thromboplastin Time (aPTT) Centrally Measured | Measurement of aPTT was performed locally and centrally using validated assays. | TS with non-sparse data | Posted | Mean | Standard Deviation | seconds | Day 3 |
|
|
|
| Secondary | aPTT Locally Measured | Measurement of aPTT was performed locally and centrally using validated assays. | TS with non-sparse data | Posted | Mean | Standard Deviation | seconds | Day 3 |
|
|
|
| Secondary | Ecarin Clotting Time (ECT) | Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT. | TS with non-sparse data | Posted | Mean | Standard Deviation | seconds | Day 3 |
|
|
|
| Secondary | Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs | Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator. | TS | Posted | Number | Participants | Baseline and 3 days |
|
|
|
| Secondary | Occurences of Clinical Outcome | Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported. | TS | Posted | Number | Participants | 3 days |
|
|
|
| 0 |
| 9 |
| 2 |
| 9 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
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| SAEs post-treatment |
|
| Title | Measurements |
|---|---|
|
| Patients with VTE related death |
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| Patients with other death |
|
| Patients with other clinical outcome |
|