V1_10APR09 ctor’s
The following information was
abstracted from
www.clinicaltrials.gov
with the study designation NCT00781391
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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