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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

December 7, 2009
June 14, 2010
May 2009
April 2010   (final data collection date for primary outcome measure)
Composite assessment of VTE events and all cause death [ Time Frame: Until day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028950 on ClinicalTrials.gov Archive Site
Incidence of bleeding events [ Time Frame: Until day 28 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
A Multi-center, Open Label Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Venous Thromboembolism
Drug: YM150
oral
Experimental: YM150 group
Intervention: Drug: YM150
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01028950
150-CL-044
No
Director, Astellas Pharma, Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP