Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01857622
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2013-05-16
Brief Title:
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
Sponsor:
Daiichi Sankyo Co Ltd
Organization:
Daiichi Sankyo
Study Overview
Official Title:
Phase III Clinical Study of DU-176b Non-valvular Atrial Fibrillation Japanese Multicenter Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment SRI
Status:
COMPLETED
Status Verified Date:
2015-01
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 non-valvular atrial fibrillation patients with severe renal impairment compared with DU-176b administered to non-valvular atrial fibrillation NVAF patients with normal renal function or mild renal impairment NormalMiRI
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