At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 80 enrolled
Drug / intervention
15mg DU-176b +2 moredrug
Likely dose
15mg DU-176bfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs
In Brief
A Phase 3 clinical trial evaluating 15mg DU-176b, 30mg DU-176b, and 1 other intervention for Venous Thromboembolism. Completed, enrolled 80 participants across 1 site.
Detailed Summary
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs. For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
Primary CompletionDec 2012
First PostedMay 2013
TodayJul 2026
First PostedMay 20, 2013
Enrollment StartMar 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.1 years ago
Interventions
15mg DU-176bdrug
30mg DU-176bdrug
Fondaparinuxdrug