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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

Page last updated: August 23, 2015

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