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NCT00680186 · ClinicalTrials.gov registry record · Phase 3
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,589
- Enrollment target
NCT00680186 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,589 participants.
The verdict
NCT00680186, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,589 participants
- Enrollment target
Study Summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.
Interventions
- DRUG Warfarin
- DRUG Dabigatran etexilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,589 participants |
| Start Date | 2008-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00680186
The ClinicalTrials.gov registry entry for NCT00680186 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,589 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 Warfarin is the first listed.
NCT00680186 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00680186 about?
NCT00680186 is a clinical study titled "Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)". The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primar...
What is the current status of trial NCT00680186?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,589 participants. The study started on 2008-04.
What interventions are being tested in trial NCT00680186?
The interventions under investigation include: Warfarin (DRUG), Dabigatran etexilate (DRUG).
Who is sponsoring clinical trial NCT00680186?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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