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Completed

NCT Number: NCT00917254

Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Thrombosis Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chugoku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects is scheduled for elective primary total knee replacement surgery
  • Written informed consent obtained before screening

Exclusion criteria

  • Subject has history of deep vein thrombosis and/or pulmonary embolism
  • Subject has a hemorrhagic disorder and/or coagulation disorder
  • Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
  • Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia
  • Subject is receiving anticoagulants/antiplatelets

Treatment and study plan

YM150

Drug

oral

Placebo

Drug

oral

Enoxaparin

Drug

injection

Primary outcomes

  1. Overall incidence of venous thromboembolism

    Time frame: 2 weeks

Secondary outcomes

  1. Incidence of individual venous thromboembolism

    Time frame: 2 weeks

  2. Incidence of bleeding events

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Knee Replacement Surgery -

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2009
Registry last updated
Jun 16, 2010

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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