Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Enoxaparin sodium 20mg; Drug: DU-176b (edoxaban)

• Registration Number: NCT01181141
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-08
• Study Completion: 2010-02
• 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: 92

Inclusion Criteria

• Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Exclusion Criteria

• Subjects with risks of hemorrhage
• Subjects with thrombolic 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
Enoxaparin sodium	Enoxaparin sodium 20mg	Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery
DU-176b	DU-176b (edoxaban)	DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery

Primary Outcome Measures

Name	Time	Method
The Incidence of Major or Clinically Relevant Non-major Bleeding	2 weeks	Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.

Secondary Outcome Measures

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