Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 4 | Active Comparator |
| |
| Arm 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xarelto (Rivaroxaban, BAY59-7939) | Drug | 10mg od |
| |
| Xarelto (Rivaroxaban, BAY59-7939) |
| Measure | Description | Time Frame |
|---|---|---|
| (Safety) Incidence of bleeding | Throughout treatment and followup period | |
| (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST | Day 14 and Day 28 |
Not provided
Not provided
Inclusion Criteria:
Japanese subjects with non-valvular AF who met all of the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chikushino-shi | Fukuoka | 818-8516 | Japan | |||
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
15mg od |
|
| Xarelto (Rivaroxaban, BAY59-7939) | Drug | 20mg od |
|
| Warfarin | Drug | Dose-adjusted warfarin based on target INR values |
|
| Fukuoka |
| Fukuoka |
| 810-8798 |
| Japan |
| Nōgata | Fukuoka | 822-0026 | Japan |
| Asahikawa | Hokkaido | 078-8214 | Japan |
| Kobe | Hyōgo | 651-0073 | Japan |
| Takarazuka | Hyōgo | 665-0022 | Japan |
| Kuwana | Mie-ken | 511-0068 | Japan |
| Sendai | Miyagi | 980-0803 | Japan |
| Sendai | Miyagi | 980-0871 | Japan |
| Tokorozawa | Saitama | 359-1141 | Japan |
| Shinagawa-ku | Tokyo | 141-0001 | Japan |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |