Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Arthroplasty, Replacement, Hip; Thrombosis

Treatments: Drug: DU-176b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00107900

DU176b-PRT007

Details and patient eligibility

About

Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

Full description

The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Enrollment: 606 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral hip replacement

Exclusion criteria

• Patients scheduled for bilateral hip replacement in same procedure
• Patients with increased risk of bleeding
• Uncontrolled hypertension (BP greater than 180/100 mmHg)
• Patients less than 111 lbs or more than 243 lbs
• Patients on long-term anticoagulants
• Patients with contraindications to venography
• Patients with medical history of venous thromboembolism
• Patients with impaired hepatic function
• Known to be pregnant
• Lactating women

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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606 participants in 6 patient groups

15mg BID

Experimental group

Description:

15mg edoxaban administered twice daily (BID)

Treatment:

Drug: DU-176b

30mg QD

Experimental group

Description:

30mg edoxaban administered once daily (QD)

Treatment:

Drug: DU-176b

30mg BID

Experimental group

Description:

30mg edoxaban administered twice daily (BID)

Treatment:

Drug: DU-176b

60mg QD

Experimental group

Description:

60mg edoxaban administered once daily (QD)

Treatment:

Drug: DU-176b

60mg BID

Experimental group

Description:

60mg edoxaban administered twice daily (BID)

Treatment:

Drug: DU-176b

120mg QD

Experimental group

Description:

120mg edoxaban administered once daily (QD)

Treatment:

Drug: DU-176b