Dose-confirmatory Bridging Study in Total Hip Replacement
NCT ID: NCT01205932
Last Updated: 2017-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
402 participants
INTERVENTIONAL
2010-09-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Arm 1
Rivaroxaban (BAY59-7939)
Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)
Arm 2
Rivaroxaban (BAY59-7939)
Daily dose: 7.5mg/day (7.5mg, once daily) for 34 to 35 days (±4 days)
Arm 3
Rivaroxaban (BAY59-7939)
Daily dose: 10mg/day (10mg, once daily) for 34 to 35 days (±4 days)
Arm 4
Enoxaparin
daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)
Interventions
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Rivaroxaban (BAY59-7939)
Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)
Rivaroxaban (BAY59-7939)
Daily dose: 7.5mg/day (7.5mg, once daily) for 34 to 35 days (±4 days)
Rivaroxaban (BAY59-7939)
Daily dose: 10mg/day (10mg, once daily) for 34 to 35 days (±4 days)
Enoxaparin
daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective THR (the first replacement of the applicable hip joint)
* Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Nagoya, Aichi-ken, Japan
Matsudo, Chiba, Japan
Narashino, Chiba, Japan
Matsuyama, Ehime, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Kōriyama, Fukushima, Japan
Asahikawa, Hokkaido, Japan
Hakodate, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kakogawa, Hyōgo, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Tsukuba, Ibaraki, Japan
Kagoshima, Kagoshima-ken, Japan
Kamakura, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Iida, Nagano, Japan
Sasebo, Nagasaki, Japan
Sasebo, Nagasaki, Japan
Kurashiki, Okayama-ken, Japan
Tomigusuku, Okinawa, Japan
Hirakata, Osaka, Japan
Hirakata, Osaka, Japan
Izumi, Osaka, Japan
Izumisano, Osaka, Japan
Kishiwada, Osaka, Japan
Kishiwada, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Sakai, Osaka, Japan
Sayama, Osaka, Japan
Suita, Osaka, Japan
Takatsuki, Osaka, Japan
Saga, Saga-ken, Japan
Nerima-ku, Tokyo, Japan
Setagaya City, Tokyo, Japan
Toyama, Toyama, Japan
Countries
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Other Identifiers
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14397
Identifier Type: -
Identifier Source: org_study_id
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