Trial record 9 of 754 for:    "Venous Thromboembolism"

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
  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:


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
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, see Learn About Clinical Studies.

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 August 19, 2014