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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total hip replacement (THR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase II study (ODIXa-OD.HIP - Study 11527).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (BAY59-7939) | Drug | Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes | Up to Day 9 (±2 days) | |
| Treatment-emergent bleeding (major, non-major clinically relevant, other non-major) | Up to Day 8 (±2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Deep vein thrombosis (total, proximal, distal) | up to Day 9 (±2 days) | |
| Symptomatic venous thromboembolism | up to Day 9 (±2 days) | |
| Major venous thromboembolism (proximal deep vein thrombosis, pulmonary embolism or venous thromboembolism-related death) |
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Inclusion Criteria:
Exclusion Criteria:
Planned, staged major orthopedic surgery within 3 months prior to elective THR or during this study
History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding*), or high bleeding risk
*: within 3 months prior to elective THR for gastrointestinal bleeding
Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: <30 mL/min)
Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator)
Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively
Planned intermittent pneumatic compression during treatment period
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 455-8530 | Japan | |||
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| Rivaroxaban (BAY59-7939) |
| Drug |
Daily dose: 7.5mg/day (7.5mg, once daily) for 34 to 35 days (±4 days) |
|
| Rivaroxaban (BAY59-7939) | Drug | Daily dose: 10mg/day (10mg, once daily) for 34 to 35 days (±4 days) |
|
| Enoxaparin | Drug | daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days) |
|
| up to Day 9 (±2 days) |
| Symptomatic venous thromboembolism | up to Day 36 (±4 days) |
| Symptomatic venous thromboembolism | within 30 days after stop of treatment with study drug. |
| Treatment-emergent bleeding (major, non-major clinically relevant, other non-major) | from the first intake of study medication to no later than 2 days after the last intake of study drug |
| Matsudo |
| Chiba |
| 271-8511 |
| Japan |
| Narashino | Chiba | 275-8580 | Japan |
| Matsuyama | Ehime | 790-8524 | Japan |
| Fukuoka | Fukuoka | 813-0017 | Japan |
| Fukuoka | Fukuoka | 814-8525 | Japan |
| Kōriyama | Fukushima | 963-8501 | Japan |
| Asahikawa | Hokkaido | 078-8237 | Japan |
| Hakodate | Hokkaido | 040-8611 | Japan |
| Sapporo | Hokkaido | 060-8648 | Japan |
| Kakogawa | Hyōgo | 675-8545 | Japan |
| Kobe | Hyōgo | 657-0068 | Japan |
| Nishinomiya | Hyōgo | 663-8501 | Japan |
| Tsukuba | Ibaraki | 305-0854 | Japan |
| Kagoshima | Kagoshima-ken | 890-0014 | Japan |
| Kamakura | Kanagawa | 247-0061 | Japan |
| Yokohama | Kanagawa | 236-0004 | Japan |
| Kumamoto | Kumamoto | 862-8505 | Japan |
| Kyoto | Kyoto | 602-8026 | Japan |
| Iida | Nagano | 395-8505 | Japan |
| Sasebo | Nagasaki | 857-0135 | Japan |
| Sasebo | Nagasaki | 857-8575 | Japan |
| Kurashiki | Okayama-ken | 710-8522 | Japan |
| Tomigusuku | Okinawa | 901-0243 | Japan |
| Hirakata | Osaka | 573-1191 | Japan |
| Hirakata | Osaka | 573-8511 | Japan |
| Izumi | Osaka | 594-0071 | Japan |
| Izumisano | Osaka | 598-8577 | Japan |
| Kishiwada | Osaka | 596-8501 | Japan |
| Kishiwada | Osaka | 596-8522 | Japan |
| Osaka | Osaka | 530-0012 | Japan |
| Osaka | Osaka | 553-0003 | Japan |
| Osaka | Osaka | 558-8558 | Japan |
| Sakai | Osaka | 599-8271 | Japan |
| Sayama | Osaka | 589-8511 | Japan |
| Suita | Osaka | 564-0082 | Japan |
| Takatsuki | Osaka | 569-1192 | Japan |
| Saga | Saga-ken | 849-8501 | Japan |
| Nerima-ku | Tokyo | 177-8521 | Japan |
| Setagaya City | Tokyo | 158-0095 | Japan |
| Toyama | Toyama | 930-8550 | Japan |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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