Dose-confirmatory Bridging Study in Total Knee Replacement

January 17, 2017 updated by: Bayer

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 Knee Replacement

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 knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 813-0017
      • Fukuoka, Japan, 819-8551
      • Kyoto, Japan, 602-8026
      • Osaka, Japan, 558-8558
      • Osaka, Japan, 530-0012
      • Saga, Japan, 849-8501
      • Saitama, Japan, 336-8522
      • Toyama, Japan, 930-8550
    • Aichi
      • Nagoya, Aichi, Japan, 455-8530
    • Chiba
      • Matsudo, Chiba, Japan, 271-8511
    • Ehime
      • Matsuyama, Ehime, Japan, 790-8524
    • Fukushima
      • Kawanuma, Fukushima, Japan, 969-6593
      • Koriyama, Fukushima, Japan, 963-8501
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8237
      • Hakodate, Hokkaido, Japan, 040-8611
      • Sapporo, Hokkaido, Japan, 060-8648
    • Hyogo
      • Kakogawa, Hyogo, Japan, 675-8545
      • Kobe, Hyogo, Japan, 657-0068
      • Nishinomiya, Hyogo, Japan, 663-8501
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-0854
    • Nagano
      • Iida, Nagano, Japan, 395-8505
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-8575
    • Okinawa
      • Tomigusuku, Okinawa, Japan, 901-0243
    • Osaka
      • 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
      • Takatsuki, Osaka, Japan, 569-1192
    • Tokyo
      • Adachi, Tokyo, Japan, 121-0064
      • Nerima-ku, Tokyo, Japan, 177-8521

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients aged 20 years or above
  • Patients undergoing elective TKR (the first replacement of the applicable knee 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 TKR 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 TKR 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Drug: Rivaroxaban (BAY59-7939)
daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
Drug: Rivaroxaban (BAY59-7939)
daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days)
Drug: Rivaroxaban (BAY59-7939)
daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days)
Experimental: Arm 2
Drug: Rivaroxaban (BAY59-7939)
daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
Drug: Rivaroxaban (BAY59-7939)
daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days)
Drug: Rivaroxaban (BAY59-7939)
daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days)
Experimental: Arm 3
Drug: Rivaroxaban (BAY59-7939)
daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
Drug: Rivaroxaban (BAY59-7939)
daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days)
Drug: Rivaroxaban (BAY59-7939)
daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days)
Active Comparator: Arm 4
Drug: Enoxaparin
daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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 13 (±2 days)
up to Day 13 (±2 days)
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
from the first intake of study medication to no later than 2 days after the last intake of study drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
deep vein thrombosis (total, proximal, distal)
Time Frame: up to Day 13 (±2 days)
up to Day 13 (±2 days)
symptomatic venous thromboembolism
Time Frame: up to Day 13 (±2 days)
up to Day 13 (±2 days)
major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)
Time Frame: up to Day 13 (±2 days)
up to Day 13 (±2 days)
symptomatic venous thromboembolism
Time Frame: within 30 days after stop of treatment with study drug
within 30 days after stop of treatment with study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Scientific Affairs, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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