CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,867 enrolled
Drug / intervention
Dabigatran +1 moredrug
Likely dose
Dabigatran 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00329238
NCT00329238Phase 3Completed
CompareCT.gov

A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

Boehringer Ingelheim·interventional·Posted May 24, 2006·Updated May 19, 2014

In Brief

A Phase 3 clinical trial evaluating Dabigatran and Warfarin for Thromboembolism. Completed, enrolled 2,867 participants across 275 sites in 33 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThromboembolism
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 24, 2006
Enrollment StartMay 1, 2006
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.1 years ago

Interventions

Dabigatrandrug

Dabigatran 150 mg BID (twice daily)

Warfarindrug

Warfarin dosed individually to maintain INR 2.0-3.0