A PHASE 2, RANDOMIZED, PARALLEL GROUP, MULTI-CENTER, MULTI-NATIONAL STUDY FOR THE EVALUATION OF SAFETY OF FOUR FIXED DOSE REGIMENS OF DU-176b IN SUBJECTS WITH NON-VALVULAR ATRIAL FIBRILLATIO
- Conditions
- Prevention of Stroke/sytemic embolic event (SEE) in subjects with non-valvular atrial fibrilation (AF)MedDRA version: 8.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis
- Registration Number
- EUCTR2007-001271-11-LV
- Lead Sponsor
- Daiichi Sankyo Pharma Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
Subjects aged 18 to 80 years;
male or female
documented non-valvular AF with a CHADS2 index score of at least 2
with or without previous treatment with warfarin and/or aspirin.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects with mitral valve disease or previous valvular heart surgery;
contraindication for anti-coagulants;
conditions associated with high risk of bleeding;
acute coronary syndromes (ACS), percutaneous coronary intervention (PCI), MI,
stroke, or coronary artery/cardiac/other major surgery within the previous 30 days;
active infective endocarditis;
life-expectancy < 12 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method