A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00942435
First received: July 16, 2009
Last updated: June 14, 2010
Last verified: June 2010

July 16, 2009
June 14, 2010
June 2009
April 2010   (final data collection date for primary outcome measure)
Composite assessment of venous thromboembolism events and all causes of death [ Time Frame: Until day 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00942435 on ClinicalTrials.gov Archive Site
  • Incidence of venous thromboembolism [ Time Frame: Until day 28 ] [ Designated as safety issue: No ]
  • Incidence of bleeding events [ Time Frame: Until day 28 ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: Until day 28 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
A Randomized, Open Label Parallel Group Mechanical Prophylaxis Controlled Comparison Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Venous Thromboembolism
  • Drug: YM150
    oral
  • Procedure: mechanical prophylaxis
    The investigator will determine the method of mechanical prophylaxis
  • Experimental: YM150 group
    Intervention: Drug: YM150
  • Active Comparator: mechanical prophylaxis group
    Intervention: Procedure: mechanical prophylaxis
Sakon M, Nakamura M. Darexaban (YM150) prevents venous thromboembolism in Japanese patients undergoing major abdominal surgery: Phase III randomized, mechanical prophylaxis-controlled, open-label study. Thromb Res. 2012 Sep;130(3):e52-9. doi: 10.1016/j.thromres.2012.06.009. Epub 2012 Jul 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients after a major abdominal surgery
  • Written informed consent obtained

Exclusion Criteria:

  • Subject has history of symptomatic 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 active bacterial endocarditis
  • Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a thrombocytopenia
  • Body weight less than 40 kg at the screening
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00942435
150-CL-042
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