CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 264 enrolled
Drug / intervention
DU-176b 15mg +2 moredrug
Likely dose
DU-176b 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01203098
NCT01203098Phase 2Completed
CompareCT.gov

A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)

Daiichi Sankyo Co., Ltd.·interventional·Posted Sep 16, 2010·Updated Feb 25, 2019

In Brief

A Phase 2 clinical trial evaluating DU-176b 15mg, DU-176b 30mg, and 1 other intervention for Venous Thromboembolism and 5 related conditions. Completed, enrolled 264 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism, Thromboembolism, Thrombosis, Embolism and Thrombosis, Deep Vein Thrombosis, Arthroplasty, Replacement, Hip
CountriesJapan, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2010
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2008
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.8 years ago

Interventions

DU-176b 15mgdrug

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

DU-176b 30mgdrug

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

Enoxaparin sodium 20 mg (=2000IU)drug

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