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 -

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00917254

Enrollment

369

Registered

2009-06-10

Start date

2009-05-31

Completion date

2010-01-31

Last updated

2010-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

YM150, Thrombosis, VTE, Knee Replacement, Anticoagulant, FXa inhibitor

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.

Interventions

DRUGYM150

oral

DRUGPlacebo

oral

DRUGEnoxaparin

injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Overall incidence of venous thromboembolism	2 weeks

Secondary

Measure	Time frame
Incidence of individual venous thromboembolism	2 weeks
Incidence of bleeding events	2 weeks

Countries

Japan, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026