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Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: June 2, 2009
Last updated: June 8, 2010
Last verified: June 2010
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.

Condition Intervention Phase
Venous Thromboembolism
Drug: YM150
Drug: Placebo
Drug: Enoxaparin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Hip Replacement Surgery

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Overall incidence of venous thromboembolism [ Time Frame: For 2 weeks ]

Secondary Outcome Measures:
  • Incidence of individual venous thromboembolism [ Time Frame: For 2 weeks ]
  • Incidence of bleeding events [ Time Frame: For 2 weeks ]

Enrollment: 610
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM150 group-1
YM150 low dose group
Drug: YM150
Experimental: YM150 group-2
YM150 high dose group
Drug: YM150
Placebo Comparator: Placebo group Drug: Placebo
Active Comparator: Enoxaparin group Drug: Enoxaparin


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

Inclusion Criteria:

  • Subjects is scheduled for elective primary total hip replacement 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, retinopathy, hypertension, or thrombocytopenia
  • Subject is receiving anticoagulants/antiplatelet agents
  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: NCT00913120

Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Shikoku, Japan
Touhoku, Japan
Korea, Republic of
Daegu, Korea, Republic of
Jeonnam, Korea, Republic of
Seoul, Korea, Republic of
Changhua, Taiwan
Chiayi, Taiwan
Taichung, Taiwan
Bangkok, Thailand
Chiangmai, Thailand
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT00913120     History of Changes
Other Study ID Numbers: 150-CL-027
Study First Received: June 2, 2009
Last Updated: June 8, 2010

Keywords provided by Astellas Pharma Inc:
FXa inhibitor
Venous thromboembolism
Arthroplasty, replacement, hip

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on April 24, 2017