Global Study to Assess the Safety and Effectiveness of DU-176b vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation (EngageAFTIMI48)
Tracking Information
Start Date ICMJE | November 2008 |
---|---|
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: October 28, 2008) | 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 ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00781391 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: October 28, 2008) |
|
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Global Study to Assess the Safety and Effectiveness of DU-176b vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation |
---|---|
Official Title ICMJE | 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) |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
|
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 16500 | ||||
---|---|---|---|---|---|
Estimated Completion Date | March 2011 | ||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 21 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00781391 |
---|---|
Responsible Party | Senior Director, Clinical Development, Daiichi Sankyo |
Study ID Numbers ICMJE | DU176b-C-U301 |
Study Sponsor ICMJE | Daiichi Sankyo Inc. |
Collaborators ICMJE | The TIMI Study Group |
Investigators ICMJE | |
Information Provided By | Daiichi Sankyo Inc. |
Source: http://clinicaltrials.gov/