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YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028950
First Posted: December 9, 2009
Last Update Posted: June 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Astellas Pharma Inc
  Purpose
To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.

Condition Intervention Phase
Venous Thromboembolism Drug: YM150 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-center, Open Label Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Composite assessment of VTE events and all cause death [ Time Frame: Until day 28 ]

Secondary Outcome Measures:
  • Incidence of bleeding events [ Time Frame: Until day 28 ]

Enrollment: 52
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM150 group Drug: YM150
oral

  Eligibility

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:

  • Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks
  • Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization
  • Written informed consent obtained

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 obtaining informed consent
  • Subject has an acute bacterial endocarditis
  • Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a body weight less than 40 kg
  • Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods
  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): NCT01028950


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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01028950     History of Changes
Other Study ID Numbers: 150-CL-044
First Submitted: December 7, 2009
First Posted: December 9, 2009
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:
Venous Thromboembolism
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