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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937911
• Other study ID #: 150-CL-041
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2009
• Last updated: June 14, 2010
• Start date: June 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hip Fractures
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• YM150
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of venous thromboembolism		Until day 12	No
Secondary	Incidence of deep vein thrombosis		Until day 35	No
Secondary	Incidence of pulmonary embolism		Until day 35	No
Secondary	All cause mortality		Until day 35	Yes
Secondary	Incidence of bleeding event		Until day 35	Yes