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Darifenacin

Phase 3

Overactive Bladder Syndrome | Small molecule | Nephrology |Novartis AG|Last Updated: Jan 23, 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-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment1,163
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00171145A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.PHASE3 COMPLETED 445Apr 1, 2004Dec 1, 2004Jan 23, 20081 United States
NCT00170755A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive BladderPHASE3 COMPLETED 718Apr 1, 2002Jan 1, 2005Jan 17, 20081 United States
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Study Endpoints
Primary Endpoints
Change from baseline in warning time at week 12.
Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.
Secondary Endpoints
Change in warning time at weeks 2 & 6.
Change in frequency of urge incontinence episodes.
Change in frequency of micturitions.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDarifenacin
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
DarifenacinDRUGDarifenacin 15 mg tablets once daily
PlaceboDRUGPlacebo tablets once daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2. * Patients capable of independent toileting and able of independently completing the patient diary. Exclusion Criteria: * Patients in whom the use of anticholinergic dr...

Countries:United States
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