Phase 3 N=716 Randomized Quadruple-blind Prevention

A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

Venous Thromboembolism

Bottom Line

View on ClinicalTrials.gov: NCT01181102 ↗

Enrolled (actual)

716

Serious AEs

3.0%

Results posted

Feb 2015

Primary outcome: Primary: Incidence of Subjects With Venous Thromboembolism Events. — 7.4; 13.9 percent of participants with VTE events — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: edoxaban (Drug); enoxaparin sodium (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Subjects With Venous Thromboembolism Events.	7.4; 13.9	<0.001 sig
SECONDARY Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.	6.2; 3.7	—

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 knee arthroplasty.

Eligibility Criteria

Inclusion Criteria

Patients undergoing unilateral total knee 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01181102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.