Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01857583
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2013-05-16
Brief Title:
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
Sponsor:
Daiichi Sankyo Co Ltd
Organization:
Daiichi Sankyo
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None