A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

Venous Thromboembolism Clinical Trial

Official title:

A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203072
• Other study ID #: DU176b-04
• Status: Completed
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: July 2008

Study information

• Verified date: January 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, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: July 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

Inclusion Criteria:

• Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

• risks of hemorrhage

• thromboembolic risks

• weight less than 40 kg

• pregnant, suspect pregnancy, or subjects who want to become pregnant

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thromboembolism
• Thrombosis
• Total Knee Arthroplasty
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• DU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
• DU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
• DU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
• DU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
• Placebo
Matching placebo oral tablets, once daily for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion 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 DVT confirmed by bilateral venography at the end of study treatment; Definite diagnosis of symptomatic 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 VTE	2 weeks
Secondary	Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding	Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug	2 weeks