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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00937820
First received: July 9, 2009
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: YM150 Long Term Study - Long-term Study in Patients With a History of Venous Thromboembolism

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of each thromboembolism [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of bleeding event [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00937820     History of Changes
Other Study ID Numbers: 150-CL-104
Study First Received: July 9, 2009
Last Updated: January 5, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 16, 2013