To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
448
Unnamed facility
Launceston, Australia
Unnamed facility
Pok Fu Lam, Hong Kong
Unnamed facility
Shatin, Hong Kong
All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"
Time frame: 16 Weeks
Incidence of symptomatic stroke
Time frame: 16 Weeks
Incidence of transient ischemic attack (TIA)
Time frame: 16 Weeks
Incidence of systemic thromboembolic event
Time frame: 16 Weeks
Incidence of the bleeding rates
Time frame: 16 Weeks
Other safety assessments
Time frame: 16 Weeks
PK, PD variables
Time frame: 16 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Unnamed facility
Kyusyu, Japan
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan
Unnamed facility
Kuala Lumpur, Malaysia
...and 8 more locations