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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DU-176b

DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery

Group Type EXPERIMENTAL

DU-176b (edoxaban)

Intervention Type DRUG

Enoxaparin sodium

Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery

Group Type ACTIVE_COMPARATOR

Enoxaparin sodium 20mg

Intervention Type DRUG

Interventions

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DU-176b (edoxaban)

Intervention Type DRUG

Enoxaparin sodium 20mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No