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V1_10APR09ctor’s                                                                  The following information was abstracted from www.clinicaltrials.gov with the study designation NCT00781391

Global Study to Assess the Safety and Effectiveness of DU-176b vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

 (ENGAGE AF TIMI 48)
This study is currently recruiting participants.
Verified by Daiichi Sankyo Inc., January 2010
 
Sponsor Daiichi Sankyo Inc.
Collaborator The TIMI Study Group
Information provided by Daiichi Sankyo Inc.
Clinicaltrials.gov Identifier NCT00781391

Purpose:  This study is to demonstrate the safety and efficacy profile, in two different dose regimens of 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.                                                                                         

Condition Intervention Phase
Stroke
Atrial Fibrillation
Embolism
Drug:  Warfarin tablets
Drug:  DU-176b tablets (high dose regimen)
Drug:  DU-176b tablets (low dose regimen)
Phase III

 

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)


Further study details as provided by Daiichi Sankyo Inc:

Primary Outcome Measures:  The primary objective is to compare DU-176b to warfarin with regard to the composite primary endpoint of stroke and systemic embolic events.
[Time Frame:  24 Months]           [Designated as safety issue:  No]

Secondary Outcome Measures:  To compare DU-176b to warfarin with regard to the composite clinical outcome of stroke, SEE (systemic embolic event), and all-cause mortality primary
endpoint of stroke and systemic embolic events.
[Time Frame:  24 Months]           [Designated as safety issue:  No]

Secondary Outcome Measures:  To compare DU-176b to warfarin with regard to the major bleeding events..
[Time Frame:  24 Months]           [Designated as safety issue:  Yes]

Estimated Enrollment:                             16,550 persons 
Study Start Date:                                    November 2008
Estimated Study Completion Date:          March 2011
Estimated Primary Completion Date:       March 2011 (final data collection date for primary outcome measure)  
    
 

Arms Assigned Interventions
1:  Active Comparator
     Warfarin tablets plus placebo DU-176b tablets
Drug:  Warfarin tablets
           Warfarin tablets plus DU-176b placebo tablets each taken once daily for 24 months
2:  Experimental
     DU-176b tablets plus warfarin placebo tablets.
Drug:  DU-176b tablets (high dose regimen)
          DU-176b tablets plus warfarin placebo tablets each taken once daily for 24 months
3:  Experimental
     DU-176b tablets plus warfarin placebo tablets.
Drug:  DU-176b tablets (low dose regimen)
          DU-176b tablets plus warfarin placebo tablets each taken once daily for 24 months

Eligibility:                                               21 years or older
Genders eligible for study:                      Both
Accepts healthy volunteers:                    No

Inclusion Criteria:
· 21 years of age or older, male or female
· Able to provide written informed consent
· History of documented atrial fibrillation within the prior 12 months
· A moderate to high risk for stroke, as defined as CHADS2 index score of at least 2

Exclusion Criteria:
· Transient atrial fibrillation secondary to other reversible disorders
· Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
· Subjects with any contraindication for anticoagulant agents
· Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
· Females of childbearing potential (females less than 2 years post-menopausal, including females with a history of tubal-ligation who are less than 2 years post-menopausal)

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