Viewing Study NCT00071279



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00071279
Status: COMPLETED
Last Update Posted: 2011-04-06
First Post: 2003-10-16

Brief Title: SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
Sponsor: Sanofi
Organization: Sanofi

Study Overview

Official Title: The Van Gogh-extension Trial a Multicenter International Randomized Double-blind Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
Status: COMPLETED
Status Verified Date: 2011-04
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 diagnosed with pulmonary embolism blood clot in the lung or deep vein thrombosis blood clot in a leg vein are at risk for these blood clots to reoccur Anticoagulant blood-thinning drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest Research has shown that when oral anticoagulants are used appropriately during this period patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur

In this study patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists acenocoumarol or warfarin or once-weekly injections of SR34006 a new anticoagulant drug will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug placebo This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo

Assignment to either SR34006 or placebo will be purely by chance Neither the patients nor their doctors will know which treatment is being given
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
Secondary IDs
Secondary ID Type Domain Link
SR34006 None None None