Dose-confirmatory Bridging Study in Total Hip Replacement
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01205932
First received: September 19, 2010
Last updated: August 15, 2012
Last verified: August 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism |
Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes [ Time Frame: Up to Day 9 (±2 days) ] [ Designated as safety issue: No ]
- Treatment-emergent bleeding (major, non-major clinically relevant, other non-major) [ Time Frame: Up to Day 8 (±2 days) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Deep vein thrombosis (total, proximal, distal) [ Time Frame: up to Day 9 (±2 days) ] [ Designated as safety issue: No ]
- Symptomatic venous thromboembolism [ Time Frame: up to Day 9 (±2 days) ] [ Designated as safety issue: No ]
- Major venous thromboembolism (proximal deep vein thrombosis, pulmonary embolism or venous thromboembolism-related death) [ Time Frame: up to Day 9 (±2 days) ] [ Designated as safety issue: No ]
- Symptomatic venous thromboembolism [ Time Frame: up to Day 36 (±4 days) ] [ Designated as safety issue: No ]
- Symptomatic venous thromboembolism [ Time Frame: within 30 days after stop of treatment with study drug. ] [ Designated as safety issue: No ]
- Treatment-emergent bleeding (major, non-major clinically relevant, other non-major) [ Time Frame: from the first intake of study medication to no later than 2 days after the last intake of study drug ] [ Designated as safety issue: Yes ]
| Enrollment: | 402 |
| Study Start Date: | September 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Rivaroxaban (BAY59-7939)
Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)
|
| Experimental: Arm 2 |
Drug: Rivaroxaban (BAY59-7939)
Daily dose: 7.5mg/day (7.5mg, once daily) for 34 to 35 days (±4 days)
|
| Experimental: Arm 3 |
Drug: Rivaroxaban (BAY59-7939)
Daily dose: 10mg/day (10mg, once daily) for 34 to 35 days (±4 days)
|
| Active Comparator: Arm 4 |
Drug: Enoxaparin
daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients aged 20 years or above
- 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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205932
Locations
| Japan | |
| Nagoya, Aichi, Japan, 455-8530 | |
| Matsudo, Chiba, Japan, 271-8511 | |
| Narashino, Chiba, Japan, 275-8580 | |
| Matsuyama, Ehime, Japan, 790-8524 | |
| Koriyama, Fukushima, Japan, 963-8501 | |
| Asahikawa, Hokkaido, Japan, 078-8237 | |
| Hakodate, Hokkaido, Japan, 040-8611 | |
| Sapporo, Hokkaido, Japan, 060-8648 | |
| Kakogawa, Hyogo, Japan, 675-8545 | |
| Kobe, Hyogo, Japan, 657-0068 | |
| Nishinomiya, Hyogo, Japan, 663-8501 | |
| Tsukuba, Ibaraki, Japan, 305-0854 | |
| Kamakura, Kanagawa, Japan, 247-0061 | |
| Yokohama, Kanagawa, Japan, 236-0004 | |
| Iida, Nagano, Japan, 395-8505 | |
| Sasebo, Nagasaki, Japan, 857-0135 | |
| Sasebo, Nagasaki, Japan, 857-8575 | |
| Kurashiki, Okayama, Japan, 710-8522 | |
| Tomigusuku, Okinawa, Japan, 901-0243 | |
| Hirakata, Osaka, Japan, 573-1191 | |
| Hirakata, Osaka, Japan, 573-8511 | |
| Izumi, Osaka, Japan, 594-0071 | |
| Izumisano, Osaka, Japan, 598-8577 | |
| Kishiwada, Osaka, Japan, 596-8522 | |
| Kishiwada, Osaka, Japan, 596-8501 | |
| Osakasayama, Osaka, Japan, 589-8511 | |
| Sakai, Osaka, Japan, 599-8271 | |
| Suita, Osaka, Japan, 564-0082 | |
| Takatsuki, Osaka, Japan, 569-1192 | |
| Nerima-ku, Tokyo, Japan, 177-8521 | |
| Setagaya, Tokyo, Japan, 158-0095 | |
| Fukuoka, Japan, 814-8525 | |
| Fukuoka, Japan, 813-0017 | |
| Kagoshima, Japan, 890-0014 | |
| Kumamoto, Japan, 862-8505 | |
| Kyoto, Japan, 602-8026 | |
| Osaka, Japan, 530-0012 | |
| Osaka, Japan, 553-0003 | |
| Osaka, Japan, 558-8558 | |
| Saga, Japan, 849-8501 | |
| Toyama, Japan, 930-8550 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Yakuhin Ltd. |
| ClinicalTrials.gov Identifier: | NCT01205932 History of Changes |
| Other Study ID Numbers: | 14397 |
| Study First Received: | September 19, 2010 |
| Last Updated: | August 15, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Bayer:
|
venous thromboembolism prevention othopaedic surgery |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013