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

Phase 2

Completed

• Conditions: Total Knee Arthroplasty; Venous Thromboembolism; Deep Vein Thrombosis
• Interventions: Drug: DU-176b; Drug: Placebo

• Registration Number: NCT01203072
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-09
• Study Completion: 2008-07
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Status Verified: 2015-01
• Results First Submitted: 2015-01-15
• Results First Submitted QC: 2015-01-15
• Results First Posted: 2015-01-26
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 523

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DU-176b 5 mg	DU-176b	-
Placebo	Placebo	-
DU-176b 60 mg	DU-176b	-
DU-176b 15 mg	DU-176b	-
DU-176b 30 mg	DU-176b	-

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Venous Thromboembolism Events.	2 weeks	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

Secondary Outcome Measures

Name	Time	Method
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding	2 weeks	Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug