Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Daiichi Sankyo Inc. The TIMI Study Group |
---|---|
Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00781391 |
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
|
Estimated Enrollment: | 16500 |
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
|
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Females of childbearing potential including the following:
Contact: Shirali Patel | 919-998-1452 | shirali.patel@quintiles.com |
Responsible Party: | Daiichi Sankyo ( Senior Director, Clinical Development ) |
Study ID Numbers: | DU176b-C-U301 |
Study First Received: | October 28, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00781391 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Systemic embolic events |
Embolism and Thrombosis Anticoagulants Heart Diseases Cerebral Infarction Embolism Stroke |
Vascular Diseases Warfarin Atrial Fibrillation Thrombosis Arrhythmias, Cardiac |
Heart Diseases Anticoagulants Hematologic Agents Vascular Diseases Warfarin Pharmacologic Actions Embolism and Thrombosis |
Pathologic Processes Embolism Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |