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SSR240600C

Phase 2

Overactive Bladder | Small molecule | Nephrology |Sanofi|Last Updated: May 26, 2016

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment463
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00564226SSR240600C Treatment in Women With Overactive BladderPHASE2 COMPLETED 345Nov 1, 2007Feb 1, 2009May 26, 20167 United States, Canada +5
NCT00174798MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.PHASE2 COMPLETED 118May 1, 2005May 1, 2006Feb 2, 201222 United States
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Study Endpoints
Primary Endpoints
Change from baseline in the number of micturitions per 24 hours
at week 12
Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
Secondary Endpoints
Changes from baseline in number of urge urinary incontinence episodes, in number of urgency episodes, in number of nocturia episodes, in volume of urine per void
at week 12
Safety of SSR240600C
at week 12
Quality of life
at week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SSR240600C Dose Level 1EXPERIMENTAL -
SSR240600C Dose Level 2EXPERIMENTAL -
SSR240600C Dose Level 3EXPERIMENTALdose level 3
TolterodineACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
SSR240600CEXPERIMENTAL -
Interventions
NameTypeDescription
SSR240600CDRUGoral administration
tolterodineDRUGoral administration
placeboDRUGoral administration
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Eligibility Criteria
Age Range18 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Diagnosis of overactive bladder Exclusion Criteria: * Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history * Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence) * Cu...

Countries:United StatesCanadaCzechiaFranceGermanyNetherlandsPortugal
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