NCT00291330

Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,564 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thromboembolism

Interventions

Type	Name	Description
DRUG	dabigatran etexilate 150 mg	twice daily
DRUG	warfarin (INR 2-3)	prn to maintain INR (2-3)

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-05-01
• First posted: 2006-02-14
• Last updated: 2014-06-06
• Results posted: 2011-02-11

Locations

250 sites across 29 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Portugal, Russia, Slovakia, South Africa, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom