Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402467
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2006-11-21
Brief Title:
An Oral Direct Factor Xa Inhibitor BAY59-7939 for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement a Dose-Ranging Study
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-12
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:
The study drug BAY59-7939 is a new drug currently being tested in the prevention of VTE It directly inhibits factor Xa a blood component in the pathway which leads to coagulation clotting of blood cells It is available as a tablet The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug Enoxaparin Enoxaparin a so-called low molecular heparin is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously In this study 4 different doses of the investigational drug BAY59-7939 will be tested in comparison to Enoxaparin You will receive during the study either one of the following BAY59-7939 treatments or Enoxaparin The following doses of BAY59-7939 will be tested Dose I Dose II Dose III Dose IV This study will run for approximately 7 months in a number of countries In total up to 600 patients may participate 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