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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 267 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01895777
The ClinicalTrials.gov registry entry for NCT01895777 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which standard of care is the first listed.
NCT01895777 reports 0 study locations.
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.
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