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NCT02104947 · ClinicalTrials.gov registry record · Phase 3
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 503
- Enrollment target
NCT02104947: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT02104947 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 503 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02104947, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 503 participants
- Enrollment target
Study Summary
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
Primary Outcome
Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100\* (pre-dose value minus post dose value)/(pre-dose value minus 100%
Interventions
- DRUG idarucizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 503 participants |
| Start Date | 2014-05-06 |
| Est. Completion | 2016-10-20 |
| Phase | Phase 3 |
What the finished NCT02104947 record still lists
NCT02104947 is an interventional study that assigns participants to a tested intervention. The registered 503 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 (35% lower).
The record links to 0 conditions, and to 1 intervention - of which idarucizumab is the first listed.
NCT02104947 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02104947 about?
NCT02104947 is a clinical study titled "Reversal of Dabigatran Anticoagulant Effect With Idarucizumab". Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
What is the current status of trial NCT02104947?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 503 participants. The study started on 2014-05-06. Estimated completion is 2016-10-20.
What interventions are being tested in trial NCT02104947?
The interventions under investigation include: idarucizumab (DRUG).
Who is sponsoring clinical trial NCT02104947?
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 NCT02104947's enrollment target sits among peer trials
503 743rd of 2000 higher than 1,258 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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