A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

Venous Thromboembolism Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS E-3 Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181102
• Other study ID #: DU176b-B-J302
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2015
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: February 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

Inclusion Criteria:

• Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

• Subjects with risks of hemorrhage

• Subjects with thromboembolic risks

• Subjects who weigh less than 40 kg

• Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• edoxaban

• enoxaparin sodium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

Japan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Subjects With Venous Thromboembolism Events.	The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.; Lower extremity Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment; Definite diagnosis of symptomatic Pulmonary Embolism (PE); Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of venous Thromboembolism (VTE)	2 weeks
Secondary	Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.		2 weeks