CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 21,105 enrolled
Drug / intervention
warfarin tablets +4 moredrug
Likely dose
Edoxaban tablets (high dose regimen-60mg)from 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/NCT00781391
NCT00781391Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

Daiichi Sankyo·interventional·Posted Oct 29, 2008·Updated Mar 5, 2019

In Brief

A Phase 3 clinical trial evaluating warfarin tablets, Edoxaban tablets (high dose regimen-60mg), and 3 other interventions for Stroke and 2 related conditions. Completed, enrolled 21,105 participants across 1,009 sites in 46 countries.

Detailed Summary

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, \& Warfarin. The expected duration of the study is 24 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Atrial Fibrillation, Embolism
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsThe TIMI Study Group

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2008
Enrollment StartNov 1, 2008
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 17.7 years ago

Interventions

warfarin tabletsdrug

Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months

Edoxaban tablets (high dose regimen-60mg)drug

Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

Edoxaban tablets (low dose regimen-30mg)drug

Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months

placebo warfarindrug

placebo warfarin

placebo edoxabandrug

placebo edoxaban