NCT00329238

Secondary Prevention of Venous Thrombo Embolism (VTE).

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,867 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thromboembolism

Interventions

Type	Name	Description
DRUG	Dabigatran	Dabigatran 150 mg BID (twice daily)
DRUG	Warfarin	Warfarin dosed individually to maintain INR 2.0-3.0

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-10-01
• First posted: 2006-05-24
• Last updated: 2014-05-19
• Results posted: 2011-09-14

Locations

275 sites across 33 countries: United States, Argentina, 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