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Completed

NCT Number: NCT01203072

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

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Deep Vein Thrombosis Embolism and Thrombosis Thromboembolism Thrombosis Total Knee Arthroplasty Vascular Diseases Venous Thrombosis

Age range

20 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing unilateral total knee arthroplasty

Exclusion criteria

  • risks of hemorrhage
  • thromboembolic risks
  • weight less than 40 kg
  • pregnant, suspect pregnancy, or subjects who want to become pregnant

Treatment and study plan

Du-176b

Drug

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

Other names: edoxaban

Placebo

Drug

Matching placebo oral tablets, once daily for 2 weeks

Primary outcomes

  1. Proportion of Subjects With Venous Thromboembolism Events.

    Time frame: 2 weeks

    The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.

    • Lower extremity DVT confirmed by bilateral venography at the end of study treatment
    • Definite diagnosis of symptomatic PE
    • Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE

Secondary outcomes

  1. Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding

    Time frame: 2 weeks

    Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Sep 16, 2010
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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