A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 250mg, 375mg and 500mg administered twice daily for 16 weeks, on top of aspirin 325mg, qd in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke
- Conditions
- prevention of thromboembolismMedDRA version: 6.1Level: PTClassification code 10061592
- Registration Number
- EUCTR2005-001256-20-IT
- Lead Sponsor
- GLAXO SMITHKLINE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method