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NCT01895777 · ClinicalTrials.gov registry record · Phase 3
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 267
- Enrollment target
NCT01895777: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01895777 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 267 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01895777, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 267 participants
- Enrollment target
Study Summary
The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.
Primary Outcome
The primary endpoint was the combined endpoint of the proportions of patients with: * Complete thrombus resolution * Freedom from recurrent VTE * Freedom from mortality related to VTE. The events outlined in the above combined primary endpoint were assessed by radiologists or other such qualified clinicians using an appropriate method such as ultrasound, echocardiography, venography, or CT scan, based on the location of the thrombus and the test used to perform the baseline assessment. The pri
Interventions
- DRUG standard of care
- DRUG dabigatran etexilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2013-09-25 |
| Est. Completion | 2019-11-14 |
| Phase | Phase 3 |
What the finished NCT01895777 record still lists
NCT01895777 is an interventional study that assigns participants to a tested intervention. The registered 267 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which standard of care is the first listed.
NCT01895777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01895777 about?
NCT01895777 is a clinical study titled "Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)". The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years o...
What is the current status of trial NCT01895777?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2013-09-25. Estimated completion is 2019-11-14.
What interventions are being tested in trial NCT01895777?
The interventions under investigation include: standard of care (DRUG), dabigatran etexilate (DRUG).
Who is sponsoring clinical trial NCT01895777?
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 NCT01895777's enrollment target sits among peer trials
267 1222nd of 2000 higher than 779 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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