Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 10:35 PM
Study NCT ID:
NCT00107900
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2005-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty
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:
Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.
Detailed Description:
The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: