Under 18, any sex, with Venous Thromboembolism or Secondary Prevention. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 MonthsPrimary· At month 6 (Week 26) and 12 (Week 52) of on treatment period
The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
6 months
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (2 to <12 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (12 to <18 Years)
0.979
0.937 – 0.993
12 months
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (2 to <12 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (12 to <18 Years)
0.979
0.937 – 0.993
Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 MonthsPrimary· At month 6 (Week 26) and month 12 (Week 52) of on treatment period
The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
6 months
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
0.889
0.433 – 0.984
Dabigatran Etexilate (2 to <12 Years)
0.894
0.706 – 0.965
Dabigatran Etexilate (12 to <18 Years)
0.753
0.675 – 0.815
12 months
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
0.889
0.433 – 0.984
Dabigatran Etexilate (2 to <12 Years)
0.831
0.592 – 0.936
Dabigatran Etexilate (12 to <18 Years)
0.691
0.603 – 0.763
Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 MonthsPrimary· At month 6 (Week 26) and 12 (Week 52) of on treatment period
The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
6 months
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (2 to <12 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (12 to <18 Years)
1.000
1.000 – 1.000
12 months
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (2 to <12 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (12 to <18 Years)
1.000
1.000 – 1.000
Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 MonthsSecondary· At month 6 (Week 26) and 12 (Week 52) of on treatment period
The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
6 months
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (2 to <12 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (12 to <18 Years)
0.979
0.935 – 0.993
12 months
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (2 to <12 Years)
1.000
1.000 – 1.000
Dabigatran Etexilate (12 to <18 Years)
0.979
0.935 – 0.993
Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment PeriodSecondary· From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days
Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
66.7
Dabigatran Etexilate (2 to <12 Years)
39.5
Dabigatran Etexilate (12 to <18 Years)
21.1
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)Secondary· At Visit 3 (day 4 after first dose of trial medication)
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
46.6
± 18.1
Dabigatran Etexilate (2 to <12 Years)
57.1
± 70.4
Dabigatran Etexilate (12 to <18 Years)
56.8
± 64.6
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)Secondary· Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
49.1
± 26.8
Dabigatran Etexilate (2 to <12 Years)
57.3
± 23.9
Dabigatran Etexilate (12 to <18 Years)
59.0
± 80.8
Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)Secondary· At Visit 3 (day 4 after first dose of trial medication)
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
52.7
± 17.6
Dabigatran Etexilate (2 to <12 Years)
64.3
± 55.7
Dabigatran Etexilate (12 to <18 Years)
69.5
± 30.3
Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)Secondary· Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
53.3
± 19.4
Dabigatran Etexilate (2 to <12 Years)
66.6
± 23.6
Dabigatran Etexilate (12 to <18 Years)
69.2
± 28.7
Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)Secondary· At Visit 3 (day 4 after first dose of trial medication)
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
37.9
± 19.5
Dabigatran Etexilate (2 to <12 Years)
40.5
± 14.6
Dabigatran Etexilate (12 to <18 Years)
45.3
± 17.4
Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)Secondary· dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Group
Value
95% CI
Dabigatran Etexilate (0 to < 2 Years)
40.0
± 24.3
Dabigatran Etexilate (2 to <12 Years)
46.0
± 18.6
Dabigatran Etexilate (12 to <18 Years)
43.4
± 17.7
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06791187 — A Study in Healthy People to Test Whether BI 1291583 Influences the Amount of Dabigatran in the Body
· Phase 1
· completed
NCT03975062 — Evaluation of Abbreviated Versus Conventional Course of Dabigatran Etexilate Before Electric Cardioversion in Patients W
· Phase 4
· unknown
NCT03070171 — Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral A
· Phase 1
· completed
NCT02239120 — Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ES
· Phase 3
· completed
NCT01895777 — Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With V
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 4 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02197416.