NCT00680186

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,589 (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 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.

Conditions

• Thromboembolism

Interventions

Type	Name	Description
DRUG	Warfarin	PRN (to maintain a target INR of 2.0-3.0)
DRUG	Dabigatran etexilate	150mg bid

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-05-01
• First posted: 2008-05-20
• Last updated: 2014-05-19
• Results posted: 2012-06-14

Locations

220 sites across 31 countries: United States, Australia, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Hungary, India, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Philippines, Poland, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom