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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937820
First Posted: July 13, 2009
Last Update Posted: January 6, 2011
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
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 Intervention Phase
Venous Thromboembolism Drug: YM150 Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Astellas Pharma Inc:

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

Secondary Outcome Measures:
  • Incidence of each thromboembolism [ Time Frame: 52 weeks ]
  • All cause mortality [ Time Frame: 52 weeks ]
  • Incidence of bleeding event [ Time Frame: 52 weeks ]

Enrollment: 87
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  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): NCT00937820


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: NCT00937820     History of Changes
Other Study ID Numbers: 150-CL-104
First Submitted: July 9, 2009
First Posted: July 13, 2009
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Astellas Pharma Inc:
YM150
Bleeding
VTE
FXa inhibitor
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