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

Venous Thromboembolism Clinical Trial

Official title:

A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181141
• Other study ID #: DU176b-B-J303
• Status: Completed
• Phase: Phase 3
• Start date: October 2008
• Est. completion date: February 2010

Study information

• Verified date: February 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• DU-176b (edoxaban)

• Enoxaparin sodium 20mg

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	The Incidence of Major or Clinically Relevant Non-major Bleeding	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.	2 weeks
Secondary	Proportion of Subjects With Venous Thromboembolism Events.		2 weeks