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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 Events

Incidence 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

Page last updated: August 20, 2015

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