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

YM150 Phase III Study - An Open-label, Multi-center Study in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00937911

Enrollment

101

Registered

2009-07-13

Start date

2009-06-30

Completion date

2010-04-30

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, Bleeding, Anticoagulant, Venous thromboembolism, FXa inhibitor

Brief summary

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.

Interventions

DRUGYM150

oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of venous thromboembolism	Until day 12

Secondary

Measure	Time frame
Incidence of deep vein thrombosis	Until day 35
Incidence of pulmonary embolism	Until day 35
All cause mortality	Until day 35
Incidence of bleeding event	Until day 35

Countries

Japan

Outcome results

None listed

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