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Dose-confirmatory Bridging Study in Total Hip Replacement

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01205932
First received: September 19, 2010
Last updated: July 17, 2013
Last verified: July 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 813-0017
Fukuoka, Japan, 814-8525
Kagoshima, Japan, 890-0014
Kumamoto, Japan, 862-8505
Kyoto, Japan, 602-8026
Osaka, Japan, 558-8558
Osaka, Japan, 553-0003
Osaka, Japan, 530-0012
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: July 17, 2013
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
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014