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SR34006

Phase 3

Pulmonary Embolism | 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
RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,215
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00071279SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein ThrombosisPHASE3 COMPLETED 1,215Nov 1, 2003Dec 1, 2005Apr 6, 201165 United States, Australia +18
NCT00062803SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary EmbolismPHASE3 COMPLETED -Jun 1, 2003Oct 1, 2005Apr 29, 200993 United States, Argentina +18
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Study Endpoints
Primary Endpoints
Symptomatic recurrent PE/DVT during the 6-month study treatment period.
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
Secondary Endpoints
Major bleeding during the 6-month study treatment period.
symptomatic recurrent PE/DVT within 6 months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
Interventions
NameTypeDescription
SR34006 (idraparinux sodium) InjectionDRUG -
SR34006DRUG -
(LMW)heparinDRUG -
Warfarin VKADRUG -
Acenocoumarol VKADRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: * Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months * Written informed consent Exclusion Criteria: * Legal age limitations (country specific) * Indication for a...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaCzechiaDenmarkFinlandFranceGermanyItalyNetherlandsNew ZealandNorwayPolandSouth AfricaSpainSwedenUnited KingdomArgentinaSwitzerland
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Competitive Landscape -Pulmonary Embolism 6 trials