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NCT00329238 · ClinicalTrials.gov registry record · Phase 3
Secondary Prevention of Venous Thrombo Embolism (VTE).
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,867
- Enrollment target
NCT00329238: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00329238 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,867 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (271% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00329238, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,867 participants
- Enrollment target
Study Summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
Primary Outcome
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Interventions
- DRUG Warfarin
- DRUG Dabigatran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,867 participants |
| Start Date | 2006-05 |
| Phase | Phase 3 |
What the finished NCT00329238 record still lists
NCT00329238 is an interventional study that assigns participants to a tested intervention. Its 2,867 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 (271% higher).
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT00329238 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00329238 about?
NCT00329238 is a clinical study titled "Secondary Prevention of Venous Thrombo Embolism (VTE).". The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have...
What is the current status of trial NCT00329238?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,867 participants. The study started on 2006-05.
What interventions are being tested in trial NCT00329238?
The interventions under investigation include: Warfarin (DRUG), Dabigatran (DRUG).
Who is sponsoring clinical trial NCT00329238?
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 NCT00329238's enrollment target sits among peer trials
2,867 81st of 2000 higher than 1,920 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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