Skip to main content
OpenTrials
Completed

NCT Number: NCT00942435

A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.

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 Thrombosis Vascular Diseases Venous Thrombosis

Age range

40 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

  • Patients after a major abdominal surgery
  • Written informed consent obtained

Exclusion criteria

  • Subject has history of symptomatic 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 active bacterial endocarditis
  • Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a thrombocytopenia
  • Body weight less than 40 kg at the screening

Treatment and study plan

YM150

Drug

oral

mechanical prophylaxis

Procedure

The investigator will determine the method of mechanical prophylaxis

Primary outcomes

  1. Composite assessment of venous thromboembolism events and all causes of death

    Time frame: Until day 12

Secondary outcomes

  1. Incidence of venous thromboembolism

    Time frame: Until day 28

  2. Incidence of bleeding events

    Time frame: Until day 28

  3. All cause mortality

    Time frame: Until day 28

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Randomized, Open Label Parallel Group Mechanical Prophylaxis Controlled Comparison Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 20, 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.