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

Phase 2

Completed

• Conditions: Thromboembolism; Thrombosis; Embolism and Thrombosis; Deep Vein Thrombosis; Venous Thromboembolism; Arthroplasty, Replacement, Hip
• Interventions: Drug: Enoxaparin sodium 20 mg (=2000IU); Drug: DU-176b 30mg; Drug: DU-176b 15mg

• Registration Number: NCT01203098
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Results First Submitted: 2015-01-15
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-06
• Results First Posted: 2015-02-09
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. Patients undergoing unilateral total hip arthroplasty
2. Patients who are 20-84 years olds

Exclusion Criteria

1. Subjects with risks of hemorrhage
2. Subjects with thromboembolic risks
3. Subjects who weigh less than 40 kg
4. 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
Enoxaparin sodium twice daily	Enoxaparin sodium 20 mg (=2000IU)	Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery
DU-176b 30mg once daily	DU-176b 30mg	DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
DU-176b 15mg once daily	DU-176b 15mg	DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery

Primary Outcome Measures

Name	Time	Method
Percentage 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 Bleedings.	2 weeks