A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery

Arthroplasty, Replacement, Knee Clinical Trial

— PEARL  

Official title:

A Phase 2b, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of YM150 in Subjects Undergoing Primary Elective Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595426
• Other study ID #: 150-CL-033
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2008
• Last updated: March 19, 2013
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 685
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is scheduled for elective primary knee arthroplasty

• Written Informed consent obtained

Exclusion Criteria:

• Subject has documented history of previous VTE

• Subject is considered to be at increased risk of VTE

• Subject has active bleeding or any condition associated with increased risk of bleeding

• Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study

Study Design

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Drug:
• YM150
Oral
• Warfarin
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of total venous thromboembolisms (VTE).		6 Weeks	No
Primary	The incidence of bleeding events classified as major by the Adjudication Committee		6 Weeks	No
Secondary	Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause		6 Weeks	No
Secondary	Incidence of the bleeding types: major, clinically relevant nonmajor, minor		6 Weeks	No

External Links

•   Link to results on JAPIC