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

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ClinicalTrials.gov Identifier: NCT00942435
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : June 16, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: YM150 Procedure: mechanical prophylaxis Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : June 2009
Primary Completion Date : April 2010
Study Completion Date : April 2010
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Composite assessment of venous thromboembolism events and all causes of death [ Time Frame: Until day 12 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942435


Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Shikoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00942435     History of Changes
Other Study ID Numbers: 150-CL-042
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: June 2010

Keywords provided by Astellas Pharma Inc:
YM150
Bleeding
VTE
FXa inhibitor
Deep Vein Thrombosis
Venous thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Darexaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants