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SL650472, Clopidogrel

Phase 2

Intermittent Claudication | Small molecule | Other |Sanofi|Last Updated: Dec 19, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment599
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00300339Mixed Antagonist of Serotonin for Claudication Optimal TherapyPHASE2 COMPLETED 599Feb 1, 2006Dec 1, 2007Dec 19, 20089 United States, Belgium +7
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Study Endpoints
Primary Endpoints
Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
Secondary Endpoints
Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,
Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SL650472, ClopidogrelDRUG -
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * 1\. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis origin (symptoms present for 6 months or longer and not significantly changed within the past 3 months); * 2\. ICD of 30...

Countries:United StatesBelgiumCanadaCzechiaGermanyMexicoRussiaSwedenUkraine
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