This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
2.5mg bid
5mg bid
10mg bid
Unnamed facility
Fukui-shi, Fukui, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Maebaru-chūō, Fukuoka, Japan
Unnamed facility
Kitahiroshima, Hokkaido, Japan
(Safety) Incidence of bleeding
Time frame: Throughout treatment and followup period
(PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST
Time frame: Day 14 and Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dose-adjusted warfarin based on target INR values
Unnamed facility
Kushiro, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Nomi, Ishikawa-ken, Japan
Unnamed facility
Yokohama, Kanagawa, Japan
Unnamed facility
Ōita, Oita Prefecture, Japan
Unnamed facility
Tokorozawa, Saitama, Japan