At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 523 enrolled
Drug / intervention
DU-176b +4 moredrug
Likely dose
DU-176b 5mgfrom 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.
A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)
In Brief
A Phase 2 clinical trial evaluating DU-176b and Placebo for Venous Thromboembolism and 2 related conditions. Completed, enrolled 523 participants across 2 sites.
Detailed Summary
The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
Primary CompletionSep 2007
Study CompletionJul 2008
First PostedSep 2010
TodayJul 2026
First PostedSep 16, 2010
Enrollment StartJul 1, 2006
Primary CompletionSep 1, 2007
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.8 years ago
Interventions
DU-176bdrug
DU-176b 5mg tablets oral, once daily for 2 weeks
DU-176bdrug
DU-176b 15mg tablets, oral once daily for 2 weeks
DU-176bdrug
DU-176b 30 mg tablets, oral, once daily for 2 weeks
DU-176bdrug
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Placebodrug
Matching placebo oral tablets, once daily for 2 weeks