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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Total Knee Arthroplasty

Treatments: Drug: Placebo; Drug: DU-176b

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203072

DU176b-04

Details and patient eligibility

About

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

Enrollment: 523 patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing unilateral total knee arthroplasty

Exclusion criteria

• risks of hemorrhage
• thromboembolic risks
• weight less than 40 kg
• pregnant, 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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523 participants in 5 patient groups, including a placebo group

DU-176b 5 mg

Experimental group

Treatment:

Drug: DU-176b

Drug: DU-176b

Drug: DU-176b

Drug: DU-176b

DU-176b 15 mg

Experimental group

Treatment:

Drug: DU-176b

Drug: DU-176b

Drug: DU-176b

Drug: DU-176b

DU-176b 30 mg

Experimental group

Treatment:

Drug: DU-176b

Drug: DU-176b

Drug: DU-176b

Drug: DU-176b

DU-176b 60 mg

Experimental group

Treatment:

Drug: DU-176b

Drug: DU-176b

Drug: DU-176b

Drug: DU-176b

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo