CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,589 enrolled
Drug / intervention
Warfarin +1 moredrug
Likely dose
Dabigatran etexilate 150mgfrom 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/NCT00680186
NCT00680186Phase 3Completed
CompareCT.gov

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

Boehringer Ingelheim·interventional·Posted May 20, 2008·Updated May 19, 2014

In Brief

A Phase 3 clinical trial evaluating Warfarin and Dabigatran etexilate for Thromboembolism. Completed, enrolled 2,589 participants across 220 sites in 31 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThromboembolism
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2008
Enrollment StartApr 1, 2008
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.1 years ago

Interventions

Warfarindrug

PRN (to maintain a target INR of 2.0-3.0)

Dabigatran etexilatedrug

150mg bid