SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00062803|
Recruitment Status : Completed
First Posted : June 17, 2003
Last Update Posted : April 29, 2009
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, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.
Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Drug: SR34006 Drug: (LMW)heparin Drug: Warfarin VKA Drug: Acenocoumarol VKA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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 (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||October 2005|
|Actual Study Completion Date :||October 2005|
- symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
- symptomatic recurrent PE/DVT within 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062803
|Study Director:||ICD CSD||Sanofi|