A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: enoxaparin sodium; Drug: edoxaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181102

DU176b-B-J302

Details and patient eligibility

About

The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Enrollment: 716 patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing unilateral total knee arthroplasty

Exclusion criteria

• Subjects with risks of hemorrhage
• Subjects with thromboembolic 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: Quadruple Blind

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716 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: 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