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Dose-confirmatory Bridging Study in Total Knee Replacement

NCT01206972 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2017-01-18

No results posted yet for this study

Summary

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.

Conditions

  • Venous Thromboembolism

Interventions

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)

DRUG

Enoxaparin

daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-05-31
Completion
2011-06-30

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206972 on ClinicalTrials.gov