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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
 Drug: YM150
Procedure: mechanical prophylaxis
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Composite assessment of venous thromboembolism events and all causes of death [ Time Frame: Until day 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 156
Study Start Date: June 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
Active Comparator: mechanical prophylaxis group Procedure: mechanical prophylaxis
The investigator will determine the method of mechanical prophylaxis

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942435

Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Shikoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00942435     History of Changes
Other Study ID Numbers: 150-CL-042
Study First Received: July 16, 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