Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062803
Status:
COMPLETED
Last Update Posted:
2009-04-29
First Post:
2003-06-16
Brief Title:
SR34006 Compared to Vitamin K Antagonist VKA in the Treatment of Pulmonary Embolism
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
The Van Gogh-PE Trial a Multicenter International Randomized Open-Label Assessor-Blind Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of LMWHeparin and Vitamin K Antagonist VKA in the Treatment of Acute Symptomatic Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who have a pulmonary embolism blood clot in the lung will be treated in this study The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant blood-thinning drug SR34006 with the standard way of treating a pulmonary embolism The standard treatment includes injections or infusions of an anticoagulant drug LMWheparin for about a week followed by anticoagulant tablets warfarin or acenocoumarol which are taken by mouth
Assignment to either SR34006 or LMWheparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors
Assignment to either SR34006 or LMWheparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors
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