A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Arthroplasty, Replacement, Hip; Thromboembolism; Venous Thromboembolism; Thrombosis; Embolism and Thrombosis; Deep Vein Thrombosis

Treatments: Drug: Enoxaparin sodium 20 mg (=2000IU); Drug: DU-176b 15mg; Drug: DU-176b 30mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203098

DU176b-B-J209

Details and patient eligibility

About

The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

Enrollment: 264 patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing unilateral total hip arthroplasty
2. Patients who are 20-84 years olds

Exclusion criteria

1. Subjects with risks of hemorrhage
2. Subjects with thromboembolic risks
3. Subjects who weigh less than 40 kg
4. 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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264 participants in 3 patient groups

DU-176b 30mg once daily

Experimental group

Description:

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

Treatment:

Drug: DU-176b 30mg

Enoxaparin sodium twice daily

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 20 mg (=2000IU)

DU-176b 15mg once daily

Experimental group

Description:

DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery

Treatment:

Drug: DU-176b 15mg