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A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

NCT01203098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2019-02-25

Study results available
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Summary

The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

Conditions

  • Venous Thromboembolism
  • Thromboembolism
  • Thrombosis
  • Embolism and Thrombosis
  • Deep Vein Thrombosis
  • Arthroplasty, Replacement, Hip

Interventions

DRUG

DU-176b 15mg

DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.

DRUG

DU-176b 30mg

DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.

DRUG

Enoxaparin sodium 20 mg (=2000IU)

Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takeshi Fuji · Osaka Koseinenkin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-12-31
Completion
2009-06-30

Countries

  • Japan
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01203098 on ClinicalTrials.gov