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NCT00558259 · ClinicalTrials.gov registry record · Phase 3
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,353
- Enrollment target
NCT00558259: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00558259 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,353 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00558259, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,353 participants
- Enrollment target
Study Summary
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).
Primary Outcome
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Interventions
- DRUG dabigatran etexilate 150 mg twice daily (BID)
- DRUG matching placebo twice daily (BID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,353 participants |
| Start Date | 2007-11 |
| Phase | Phase 3 |
What the finished NCT00558259 record still lists
NCT00558259 is an interventional study that assigns participants to a tested intervention. Its 1,353 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 (75% higher).
The record links to 0 conditions, and to 2 interventions - of which dabigatran etexilate 150 mg twice daily (BID) is the first listed.
NCT00558259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00558259 about?
NCT00558259 is a clinical study titled "Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE". The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of trea...
What is the current status of trial NCT00558259?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,353 participants. The study started on 2007-11.
What interventions are being tested in trial NCT00558259?
The interventions under investigation include: dabigatran etexilate 150 mg twice daily (BID) (DRUG), matching placebo twice daily (BID) (DRUG).
Who is sponsoring clinical trial NCT00558259?
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 NCT00558259's enrollment target sits among peer trials
1,353 181st of 2000 higher than 1,820 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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