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Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism

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ClinicalTrials.gov Identifier: NCT00937820
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : January 6, 2011
Information provided by:
Astellas Pharma Inc

Brief Summary:
The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in patients with a history of venous thromboembolism.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: YM150 Long Term Study - Long-term Study in Patients With a History of Venous Thromboembolism
Study Start Date : June 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: YM150 group Drug: YM150

Primary Outcome Measures :
  1. Joint incidence of deep vein thromboembolism or pulmonary thromboembolism [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Incidence of each thromboembolism [ Time Frame: 52 weeks ]
  2. All cause mortality [ Time Frame: 52 weeks ]
  3. Incidence of bleeding event [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis
  • 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, retinopathy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a body weight less than 40 kg

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): NCT00937820

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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00937820     History of Changes
Other Study ID Numbers: 150-CL-104
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Astellas Pharma Inc:
FXa inhibitor
Venous thromboembolism

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