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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: Enoxaparin sodium 20mg; Drug: DU-176b (edoxaban)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181141

DU176b-B-J303

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

DU-176b

Experimental group

Description:

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

Treatment:

Drug: DU-176b (edoxaban)

Enoxaparin sodium

Active Comparator group

Description:

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

Treatment:

Drug: Enoxaparin sodium 20mg