Skip to main content
OpenTrials
Completed

NCT Number: NCT00937911

Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

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 undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture 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
  • Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a body weight less than 40 kg

Treatment and study plan

YM150

Drug

oral

Primary outcomes

  1. Incidence of venous thromboembolism

    Time frame: Until day 12

Secondary outcomes

  1. Incidence of deep vein thrombosis

    Time frame: Until day 35

  2. Incidence of pulmonary embolism

    Time frame: Until day 35

  3. All cause mortality

    Time frame: Until day 35

  4. Incidence of bleeding event

    Time frame: Until day 35

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

YM150 Phase III Study - An Open-label, Multi-center Study in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 13, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.