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

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM150
Placebo
Enoxaparin
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring YM150, Thrombosis, VTE, Knee Replacement, Anticoagulant, FXa inhibitor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects is scheduled for elective primary total knee 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/antiplatelets

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

YM150 group-1

YM150 group-2

Placebo group

Enoxaparin group

Arm Description

YM150 low dose group

YM150 high dose group

Outcomes

Primary Outcome Measures

Overall incidence of venous thromboembolism

Secondary Outcome Measures

Incidence of individual venous thromboembolism
Incidence of bleeding events

Full Information

First Posted
June 8, 2009
Last Updated
June 14, 2010
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00917254
Brief Title
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
Official Title
Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Knee Replacement Surgery -
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
YM150, Thrombosis, VTE, Knee Replacement, Anticoagulant, FXa inhibitor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YM150 group-1
Arm Type
Experimental
Arm Description
YM150 low dose group
Arm Title
YM150 group-2
Arm Type
Experimental
Arm Description
YM150 high dose group
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Title
Enoxaparin group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
YM150
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
injection
Primary Outcome Measure Information:
Title
Overall incidence of venous thromboembolism
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Incidence of individual venous thromboembolism
Time Frame
2 weeks
Title
Incidence of bleeding events
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects is scheduled for elective primary total knee 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/antiplatelets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyusyu
Country
Japan
City
Touhoku
Country
Japan
City
Changhua
Country
Taiwan
City
Chia-Yi
Country
Taiwan
City
Kaohsiung
Country
Taiwan
City
Taichung
Country
Taiwan
City
Bangkok
Country
Thailand
City
Chiangmai
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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