Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thromboembolism
Intervention: 15mg DU-176b (Drug); 30mg DU-176b (Drug); Fondaparinux (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Daiichi Sankyo Co., Ltd. Official(s) and/or principal investigator(s): Takeshi Fuji, VP, Principal Investigator, Affiliation: Osaka Koseinenkin Hospital
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.
Clinical Details
Official title: Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of Any Adjudicated Bleeding EventsIncidence of Adverse Events Incidence of Adverse Drug Reactions Plasma Concentration of DU-176b Plasma Concentration of D21-2393
Secondary outcome: Incidence of Adjudicated Thromboembolic Events
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Toyooka Chuo Hospital, Asahikawa, Hokkaido Prefecture 078-8237, Japan
Additional Information
Starting date: March 2012
Last updated: February 25, 2015
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