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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: July 9, 2009
Last updated: June 14, 2010
Last verified: June 2010
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 Intervention Phase
Venous Thromboembolism Drug: YM150 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

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

Secondary Outcome Measures:
  • Incidence of deep vein thrombosis [ Time Frame: Until day 35 ]
  • Incidence of pulmonary embolism [ Time Frame: Until day 35 ]
  • All cause mortality [ Time Frame: Until day 35 ]
  • Incidence of bleeding event [ Time Frame: Until day 35 ]

Enrollment: 101
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


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00937911

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

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT00937911     History of Changes
Other Study ID Numbers: 150-CL-041
Study First Received: July 9, 2009
Last Updated: June 14, 2010

Keywords provided by Astellas Pharma Inc:
Venous thromboembolism
FXa inhibitor

Additional relevant MeSH terms:
Venous Thromboembolism
Hip Fractures
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on August 18, 2017