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A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

NCT01203072 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2019-02-25

Study results available
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Summary

The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Conditions

  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Total Knee Arthroplasty

Interventions

DRUG

DU-176b

DU-176b 5mg tablets oral, once daily for 2 weeks

DRUG

DU-176b

DU-176b 15mg tablets, oral once daily for 2 weeks

DRUG

DU-176b

DU-176b 30 mg tablets, oral, once daily for 2 weeks

DRUG

DU-176b

DU-176b 60 mg tablets, oral, once daily for 2 weeks

DRUG

Placebo

Matching placebo oral tablets, once daily for 2 weeks

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takeshi Fuji, Director · Osaka Koseinekin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-09-30
Completion
2008-07-31

Countries

  • Japan

Study Locations

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Entities

Drugs

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 NCT01203072 on ClinicalTrials.gov