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Safety and Efficacy Trial Evaluating the Use of SanOrg34006 in the Treatment of Deep Vein Thrombosis (DVT)
This study is currently recruiting patients.
| Sponsored by: | Sanofi-Synthelabo |
|---|---|
| Information provided by: | Sanofi-Synthelabo |
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Deep Vein Thrombosis |
Drug: SanOrg34006 Drug: LMW heparin Drug: Unfractionated heparin Drug: Vitamin K antagonist (VKA) |
Phase III |
MedlinePlus related topics: Circulatory Disorders; Thrombophlebitis
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Study start: July 2003
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location
and Contact
Information
More Information
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