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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,564 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00291330
The ClinicalTrials.gov registry entry for NCT00291330 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,564 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 is the first listed.
NCT00291330 reports 0 study locations.
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.
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