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

Venous Thromboembolism Clinical Trial

Official title:

Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Hip Replacement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913120
• Other study ID #: 150-CL-027
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 2, 2009
• Last updated: June 8, 2010
• Start date: May 2009
• Est. completion date: March 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 AgencyTaiwan: Department of HealthKorea: Food and Drug AdministrationThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 hip replacement surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects is scheduled for elective primary total hip 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/antiplatelet agents

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• YM150
oral
• Placebo
oral
• Enoxaparin
injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall incidence of venous thromboembolism		For 2 weeks	No
Secondary	Incidence of individual venous thromboembolism		For 2 weeks	No
Secondary	Incidence of bleeding events		For 2 weeks	Yes