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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01028950
First received: December 7, 2009
Last updated: June 14, 2010
Last verified: June 2010
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of bleeding events [ Time Frame: Until day 28 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01028950     History of Changes
Other Study ID Numbers: 150-CL-044
Study First Received: December 7, 2009
Last Updated: June 14, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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