A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prevention; Venous Thromboembolism
Intervention: edoxaban (Drug); enoxaparin sodium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Daiichi Sankyo Co., Ltd. Official(s) and/or principal investigator(s): Takeshi Fuji, Principal Investigator, Affiliation: Osaka Koseinenkin Hospital
Summary
The objective of this study is to assess the efficacy and safety of DU-176b compared with
enoxaparin sodium for the prevention of venous thromboembolism in patients after elective
total hip arthroplasty.
Clinical Details
Official title: A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-5 Trial)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of Subjects With Venous Thromboembolism Events
Secondary outcome: Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
Eligibility
Minimum age: 20 Years.
Maximum age: 84 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients undergoing unilateral total hip arthroplasty
Exclusion Criteria:
- Subjects with risks of hemorrhage
- Subjects with thromboembolic risks
- Subjects who weigh less than 40 kg
- Subjects who are pregnant or suspect pregnancy, or subjects who want to become
pregnant
Locations and Contacts
Osaka, Japan
Tokyo, Japan
Additional Information
Starting date: May 2009
Last updated: February 3, 2015
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