NCT00067093

Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,452 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who have deep vein thrombosis (blood clot in the leg) 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 administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
DRUG	SanOrg34006
DRUG	LMW heparin
DRUG	Unfractionated heparin
DRUG	Vitamin K antagonist (VKA)

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2003-08-13
• Last updated: 2011-04-06

Locations

24 sites across 1 country: United States