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

June 14, 2010 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Chugoku, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Shikoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YM150 group
Drug: YM150
oral
Active Comparator: mechanical prophylaxis group
Procedure: mechanical prophylaxis
The investigator will determine the method of mechanical prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite assessment of venous thromboembolism events and all causes of death
Time Frame: Until day 12
Until day 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of venous thromboembolism
Time Frame: Until day 28
Until day 28
Incidence of bleeding events
Time Frame: Until day 28
Until day 28
All cause mortality
Time Frame: Until day 28
Until day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 16, 2009

First Posted (Estimate)

July 20, 2009

Study Record Updates

Last Update Posted (Estimate)

June 16, 2010

Last Update Submitted That Met QC Criteria

June 14, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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