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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Toyooka Chuo Hospital
Asahikawa, Hokkaido Prefecture, Japan
Incidence of Any Adjudicated Bleeding Events
Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).
Time frame: 14 days
Incidence of Adverse Events
Time frame: 1 month
Incidence of Adverse Drug Reactions
Time frame: 1 month
Plasma Concentration of DU-176b
Time frame: 14 days
Plasma Concentration of D21-2393
Time frame: 14 days
Incidence of Adjudicated Thromboembolic Events
Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).
Time frame: 1 month
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