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Tolterodine

Phase 4FDA approved

Urinary Incontinence | Small molecule | Nephrology |Viatris Inc.|Trials Updated: Jan 27, 2021

Tolterodine development status

FDA approval on record Mar 25, 1998
Approval holderUpjohn
ApplicationNDA020771
Highest phase Phase 4 run by Novartis (NCT00413790)
Phase scored for VTRSPhase 3
Registered trials 7 across 5 sponsors since Aug 2004

Label indication DETROL Tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. FDA label

Tolterodine target and mechanism

ModalitySmall molecule

Also known as tolterodine extended release capsule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment304

FDA Designations

No designations recorded

Tolterodine clinical trials

Tolterodine · 3 trials · 3 indications

Phase 3 1Phase 1 2
NCT00139724Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release TabletUrinary Incontinence
COMPLETED260 Analytics
PHASE3COMPLETED
Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet
Urinary Incontinence
NCT00139724260
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Study Endpoints

Primary Endpoints

To evaluate the efficacy of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine
0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of tolterodine
0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
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

To evaluate the safety of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine.
0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT
0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL4 mg tolterodine extended release capsules, administered with water and under fasting condition.
BEXPERIMENTAL4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.
CEXPERIMENTAL4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.
DEXPERIMENTAL4 mg MPB-RR1, administered without water and under fed condition.
EEXPERIMENTAL4 mg MPB-RR1, administered with water and under fasting condition.
TolterodineEXPERIMENTAL -

Interventions

NameTypeDescription
tolterodine extended release capsuleDRUG -
tolterodine tartrateDRUG4 mg single dose of extended release capsules
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 to 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Subjects with a diagnosis of overactive bladder. Exclusion Criteria: * Subjects with significant stress incontinence as determined by the investigator. * Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times in the last year.

Countries:ChinaSingaporeSwitzerland
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