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Tolterodine & Pregabalin

Phase 2

Overactive Bladder | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Dec 21, 2009

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment188
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00746681Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive BladderPHASE2 COMPLETED 188Dec 1, 2005Nov 1, 2006Dec 21, 200923 Czechia, Lithuania +4
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Study Endpoints
Primary Endpoints
Change in mean voided volume per micturition (from baseline).
4 weeks
Secondary Endpoints
Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
4 Weeks
Percentage and absolute change in urgency episode frequency
4 Weeks
Mean severity of urgency episodes
4 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALTolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily
BACTIVE_COMPARATORTolterodine SR 4 mg once daily
CPLACEBO_COMPARATORPlacebo
DEXPERIMENTALTolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily
EEXPERIMENTALPregabalin 150 mg twice daily
Interventions
NameTypeDescription
Tolterodine & PregabalinDRUGTolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
TolterodineDRUGTolterodine SR, Oral, 4 mg, once daily for 4 weeks
PlaceboDRUGPlacebo, Oral, twice daily for 4 weeks
PregabalinDRUGPregabalin, Oral, 150 mg twice daily for 4 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Women \> 18 years Old * Diagnosis of OAB (micturition frequency \>/= 8 times per day; urinary urgency \>/= 4 times per week) Exclusion Criteria: * Subjects with symptoms of overactive bladder for less than 6 months prior to randomization. * Significant stress incontinence as...

Countries:CzechiaLithuaniaNorwaySlovakiaSwedenUnited Kingdom
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