This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
102
10mg od
15mg od
20mg od
Unnamed facility
Chikushino-shi, Fukuoka, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Nōgata, Fukuoka, Japan
Unnamed facility
Asahikawa, 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
Kobe, Hyōgo, Japan
Unnamed facility
Takarazuka, Hyōgo, Japan
Unnamed facility
Kuwana, Mie-ken, Japan
Unnamed facility
Sendai, Miyagi, Japan
Unnamed facility
Sendai, Miyagi, Japan
Unnamed facility
Tokorozawa, Saitama, Japan
...and 1 more locations