Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs.

For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Edoxaban; Fondaparinux; PENTA

Criteria

Inclusion Criteria:

• Patients with SRI or MiRI undergoing orthopedic surgery of the lower limbs

Exclusion Criteria:

• Patients who are on hemodialysis or are scheduled to undergo hemodialysis during the study period

• Patients who are at a significantly high risk for bleeding or thromboembolism

• Patients who are receiving another antithrombotic therapy and are unable to suspend the therapy

• Patients who have evidence of hepatic function test abnormalities