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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,353 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00558259
The ClinicalTrials.gov registry entry for NCT00558259 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,353 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 dabigatran etexilate 150 mg twice daily (BID) is the first listed.
NCT00558259 reports 0 study locations.
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.
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