Status:
COMPLETED
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 patie...
Eligibility Criteria
Inclusion
- Patients with SRI or MiRI undergoing orthopedic surgery of the lower limbs
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01857583
Start Date
March 1 2012
End Date
December 1 2012
Last Update
March 5 2019
Active Locations (1)
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1
Toyooka Chuo Hospital
Asahikawa, Hokkaido Prefecture, Japan, 078-8237