Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Knee Replacement Surgery -
1 other identifier
interventional
369
3 countries
13
Brief Summary
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 knee replacement surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJune 16, 2010
June 1, 2010
8 months
June 8, 2009
June 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall incidence of venous thromboembolism
2 weeks
Secondary Outcomes (2)
Incidence of individual venous thromboembolism
2 weeks
Incidence of bleeding events
2 weeks
Study Arms (4)
YM150 group-1
EXPERIMENTALYM150 low dose group
YM150 group-2
EXPERIMENTALYM150 high dose group
Placebo group
PLACEBO COMPARATOREnoxaparin group
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects is scheduled for elective primary total knee replacement surgery
- Written informed consent obtained before screening
You may not qualify if:
- 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/antiplatelets
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyusyu, Japan
Unknown Facility
Tōhoku, Japan
Unknown Facility
Changhua, Taiwan
Unknown Facility
Chiayi City, Taiwan
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Bangkok, Thailand
Unknown Facility
Chiang Mai, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
May 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
June 16, 2010
Record last verified: 2010-06