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Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

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ClinicalTrials.gov Identifier: NCT00937911
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : June 16, 2010
Sponsor:
Information provided by:
Astellas Pharma Inc

Brief Summary:
The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: YM150 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: YM150 Phase III Study - An Open-label, Multi-center Study in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
Study Start Date : June 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: YM150 group Drug: YM150
oral



Primary Outcome Measures :
  1. Incidence of venous thromboembolism [ Time Frame: Until day 12 ]

Secondary Outcome Measures :
  1. Incidence of deep vein thrombosis [ Time Frame: Until day 35 ]
  2. Incidence of pulmonary embolism [ Time Frame: Until day 35 ]
  3. All cause mortality [ Time Frame: Until day 35 ]
  4. Incidence of bleeding event [ Time Frame: Until day 35 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery
  • 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, retinopacy, myocardial infarction or stroke
  • Subject is receiving anticoagulants/antiplatelet agents
  • Subject has a body weight less than 40 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937911


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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00937911     History of Changes
Other Study ID Numbers: 150-CL-041
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: June 2010

Keywords provided by Astellas Pharma Inc:
YM150
Bleeding
Anticoagulant
Venous thromboembolism
FXa inhibitor

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Hip Fractures
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Darexaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants