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NCT02197416 · ClinicalTrials.gov registry record · Phase 3
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT02197416: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT02197416 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02197416, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG dabigatran etexilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2014-09-29 |
| Est. Completion | 2019-11-19 |
| Phase | Phase 3 |
What the finished NCT02197416 record still lists
NCT02197416 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which dabigatran etexilate is the first listed.
NCT02197416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02197416 about?
NCT02197416 is a clinical study titled "Safety of Dabigatran Etexilate in Blood Clot Prevention in Children". 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.
What is the current status of trial NCT02197416?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2014-09-29. Estimated completion is 2019-11-19.
What interventions are being tested in trial NCT02197416?
The interventions under investigation include: dabigatran etexilate (DRUG).
Who is sponsoring clinical trial NCT02197416?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02197416's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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