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

Phase 3

Completed

• Conditions: Venous Thromboembolism; Prevention
• Interventions: Drug: edoxaban; Drug: enoxaparin sodium

• Registration Number: NCT01181167
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief 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 hip arthroplasty.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Results First Submitted: 2015-01-15
• Results First Submitted QC: 2015-01-15
• Results First Posted: 2015-01-26
• Status Verified: 2015-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

• Patients undergoing unilateral total hip 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DU-176b	edoxaban	DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.
enoxaparin sodium	enoxaparin sodium	enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.

Primary Outcome Measures

Name	Time	Method
Incidence 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