Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398905
Status:
COMPLETED
Last Update Posted:
2009-05-08
First Post:
2006-11-07
Brief Title:
Dose-Ranging Study of BAY 59-7939 on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Controlled Double-Blind Randomised Dose-Ranging Study on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939
Status:
COMPLETED
Status Verified Date:
2009-05
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:
ODIXa-HIP2
Brief Summary:
Patients undergoing surgery especially hip and knee surgery are at high risk for VTE The administration of drugs for thromboprophylaxis such as heparins significantly lowers that risk but heparins have to be applied by injections below the skin The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials Enoxaparin a so-called low molecular weight heparin is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin The following doses of BAY 59-7939 were tested 25 mg twice daily 5 mg total daily dose 5 mg twice daily 10 mg total daily dose 10 mg twice daily 20 mg total daily dose 20 mg twice daily 40 mg total daily dose and 30 mg twice daily 60 mg total daily dose This study ran for approximately 7 months in a number of countries In total 726 patients were enrolled in this study
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