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NCT00291330 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,564
- Enrollment target
NCT00291330: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00291330 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,564 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (232% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00291330, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,564 participants
- Enrollment target
Study Summary
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.
Primary Outcome
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Interventions
- DRUG dabigatran etexilate 150 mg
- DRUG warfarin (INR 2-3)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,564 participants |
| Start Date | 2006-02 |
| Phase | Phase 3 |
What the finished NCT00291330 record still lists
NCT00291330 is an interventional study that assigns participants to a tested intervention. Its 2,564 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (232% higher).
The record links to 0 conditions, and to 2 interventions - of which dabigatran etexilate 150 mg is the first listed.
NCT00291330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00291330 about?
NCT00291330 is a clinical study titled "Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism". The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembo...
What is the current status of trial NCT00291330?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,564 participants. The study started on 2006-02.
What interventions are being tested in trial NCT00291330?
The interventions under investigation include: dabigatran etexilate 150 mg (DRUG), warfarin (INR 2-3) (DRUG).
Who is sponsoring clinical trial NCT00291330?
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 NCT00291330's enrollment target sits among peer trials
2,564 85th of 2000 higher than 1,916 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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