Status:
COMPLETED
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The sub...
Eligibility Criteria
Inclusion
- Male or female subjects 18 to 80 years of age
- Non-valvular AF supported by abnormal ECG documented for two times (interval of more than 1 week) within 6 months prior to randomization.
- CHADS2 Score of at least 1.
Exclusion
- Subjects with mitral valve disease
- Subjects with previous valvular heart surgery
- Contraindication for anticoagulants
- Conditions associated with high risk of bleeding
- Acute coronary syndromes (ACS), percutaneous coronary intervention (PCI), MI, stroke, transient ischemic attack (TIA) or coronary artery/cardiac/other major surgery within the previous 30 days
- Active infective endocarditis or life-expectancy \< 12 months
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00806624
Start Date
October 1 2007
End Date
November 1 2009
Last Update
February 26 2019
Active Locations (4)
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1
Hong Kong, China
2
Singapore, Singapore
3
Seoul, South Korea
4
Taipei, Taiwan