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Tolterodine

Phase 3

Overactive Bladder | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Jan 27, 2021

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 Trials2
Total Enrollment2,445
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00611026Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.PHASE3 COMPLETED 2,417 — — Feb 1, 2008Oct 1, 2009Feb 2, 2011227 United States, Brazil +23
NCT00481728Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.PHASE1 COMPLETED 28 — — Jun 1, 2007Dec 1, 2008Jan 27, 20211 Switzerland
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Study Endpoints
Primary Endpoints
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
Baseline, Week 12

UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients
Secondary Endpoints
Change From Baseline in Mean Voided Volume Per Micturition
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Mean Number of Micturitions Per 24 Hours
Baseline, Week 1, Week 4, Week 12
Percent Change From Baseline of Micturitions Per 24 Hours
Baseline, Week 1, Week 4, Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR -
2PLACEBO_COMPARATOR -
3EXPERIMENTAL -
TolterodineEXPERIMENTAL -
Interventions
NameTypeDescription
Tolterodine ERDRUGThe tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
PlaceboDRUGPlacebo treatment will be once daily(QD) for 12 weeks.
FesoterodineDRUGThe fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.
TolterodineDRUGSingle dose per patient as determined by protocol.
Filling cystometryPROCEDUREThis is a procedure.
Intravesical neurostimulationPROCEDUREThis is a procedure.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites227

Inclusion Criteria: * Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit. * Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit * Mea...

Countries:United StatesBrazilBulgariaCanadaColombiaCosta RicaEstoniaGermanyGreeceHungaryIndiaIrelandLatviaLithuaniaMalaysiaPolandRomaniaRussiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenUkraineSwitzerland
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