Phase 2 N=264 Randomized Quadruple-blind Prevention

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

Venous Thromboembolism · Thromboembolism · Thrombosis · Embolism and Thrombosis · Deep Vein Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT01203098 ↗

Enrolled (actual)

264

Serious AEs

1.5%

Results posted

Feb 2015

Primary outcome: Primary: Percentage of Subjects With Venous Thromboembolism Events — 3.8; 2.8; 4.1 percent of participants with VTE event

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: DU-176b 15mg (Drug); DU-176b 30mg (Drug); Enoxaparin sodium 20 mg (=2000IU) (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Venous Thromboembolism Events	3.8; 2.8; 4.1	—
SECONDARY Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.	2.2; 1.2; 2.3	—

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.

Eligibility Criteria

Inclusion Criteria

Patients undergoing unilateral total hip arthroplasty
Patients who are 20-84 years olds

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 (NCT01203098). 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.