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

Phase 3 Completed 610 enrolled Daiichi Sankyo

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2009-05
Primary completion: 2010-01
Completion: 2010-03

Outcome

Met primary endpoint

paper Edoxaban was superior to enoxaparin in prevention of VTE following TKA and THA, with comparable rates of bleeding events. PMID 27980462 ↗

Publications

Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. Thromb J. 2016 Dec 1;14:48. doi: 10.1186/s12959-016-0121-1. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Edoxaban	Small molecule	30 mg	Oral
Comparator	Enoxaparin sodium	Other / unclassified	20 mg	Subcutaneous