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SanOrg34006

Phase 3

Deep Vein Thrombosis | Small molecule | Other |Sanofi|Last Updated: Apr 6, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment1,452
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00067093Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)PHASE3 COMPLETED 1,452May 1, 2003Sep 1, 2005Apr 6, 201124 United States
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Study Endpoints
Primary Endpoints
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
Secondary Endpoints
symptomatic recurrent PE/DVT within 6 months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SanOrg34006DRUG -
LMW heparinDRUG -
Unfractionated heparinDRUG -
Vitamin K antagonist (VKA)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Confirmed acute symptomatic DVT * Written informed consent Exclusion Criteria: * Legal lower age limitations * Patients with symptomatic pulmonary embolism * Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT * Other...

Countries:United States
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