A Phase 2 interventional study of dabigatran etexilate in Venous Thromboembolism, sponsored by Boehringer Ingelheim. Completed at 2 sites in Canada. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
708 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.
This study's enrollment of 9 is below the median of 257 across 390 interventional studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
open label; patient to receive dabigatran etexilate BID for three days
Drug: dabigatran etexilate
2.14 mg/kg BID to a max 150 mg BID
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.
Time frame: 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.
Time frame: 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
Time frame: 3 days
Plasma Concentration of Total Dabigatran
Plasma concentration of total dabigatran measured at 72 hours after first dose
Time frame: Day 3
Thrombin Time (TT) Centrally Measured
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Time frame: Day 3
TT Locally Measured
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
Time frame: Day 3
Activated Partial Thromboplastin Time (aPTT) Centrally Measured
Measurement of aPTT was performed locally and centrally using validated assays.
Time frame: Day 3
aPTT Locally Measured
Measurement of aPTT was performed locally and centrally using validated assays.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 days
| Milestone | All Patients (Pat.) |
|---|---|
| Started | 9 |
| Pat. received 75mg followed by 100mg | 3 |
| Pat. received 100mg followed by 125mg | 3 |
| Pat. received 125mg followed by 150mg | 2 |
| Pat. received single dose 75mg | 1 |
| Completed | 8 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Participants | All Patients |
|---|---|
| Number of Patients With Bleeding Events (Major and Minor) | 0 |
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.
| Participants | All Patients |
|---|---|
| DRAEs on-treatment | 2 |
| SAEs on-treatment | 0 |
| DRAEs post-treatment | 0 |
| SAEs post-treatment | 1 |
Plasma concentration of free dabigatran measured at 72 hours after first dose
| ng/ml | All Patients |
|---|---|
| Patients with 75mg dose followed by 100mg (N=3) | 28.0 ± 12.8 |
| Patients with 100mg dose followed by 125mg (N=3) | 41.6 ± 66.5 |
Plasma concentration of total dabigatran measured at 72 hours after first dose
| ng/ml | All Patients |
|---|---|
| Patients with 75mg dose followed by 100mg (N=3) | 34.2 ± 3.56 |
| Patients with 100mg dose followed by 125mg (N=3) | 58.2 ± 48.7 |
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
| seconds | All Patients |
|---|---|
| Patients with 75mg dose followed by 100mg (N=3) | 36.9 ± 3.61 |
| Patients with 100mg dose followed by 125mg (N=3) | 37.4 ± 3.97 |
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
| seconds | All Patients |
|---|---|
| Patients with 75mg dose followed by 100mg (N=3) | 33.5 ± 2.15 |
| Patients with 100mg dose followed by 125mg (N=3) | 36.8 ± 5.72 |
Measurement of aPTT was performed locally and centrally using validated assays.
| seconds | All Patients |
|---|---|
| Patients with 75mg dose followed by 100mg (N=3) | 38.6 ± 2.94 |
| Patients with 100mg dose followed by 125mg (N=3) | 47.4 ± 4.42 |
Measurement of aPTT was performed locally and centrally using validated assays.
| seconds | All Patients |
|---|---|
| Patients with 75mg dose followed by 100mg (N=3) | 29.9 ± 2.68 |
| Patients with 100mg dose followed by 125mg (N=3) | 33.6 ± 0.896 |
Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.
| seconds | All Patients |
|---|---|
| Patients with 75mg dose followed by 100mg (N=3) | 43.3 ± 1.31 |
| Patients with 100mg dose followed by 125mg (N=3) | 49.6 ± 11.6 |
Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
| Participants | All Patients |
|---|---|
| Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs | 0 |
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.
| Participants | All Patients |
|---|---|
| Patients with recurrent VTE | 1 |
| Patients with PTS | 0 |
| Patients with PE | 0 |
| Patients with VTE related death | 0 |
| Patients with other death | 0 |
| Patients with other clinical outcome | 0 |
Collected over 3 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | — | 0/9 (0%) | 2/9 (22.2%) |
| Event | All Patients |
|---|---|
| Abdominal discomfortGastrointestinal disorders | 1/9 |
| Abdominal painGastrointestinal disorders | 1/9 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/9 |
| Age, Continuous(years) | All Patients |
|---|---|
| Mean | 15.7 ± 1.3 |
| Sex: Female, Male(Participants) | All Patients |
|---|---|
| Female | 6 |
| Male | 3 |
Plan to share: No — 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
Ran from Jun 2009 to primary completion in Feb 2012, 32 months.
Results were first posted in Mar 2013, 1 year 1 month after primary completion.
Of 27 phase 2 interventional studies under Venous Thromboembolism, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 50. This study's 32 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dabigatran