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UK-369,003

Phase 2

Urinary Bladder, Overactive | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Mar 23, 2011

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 Trials1
Total Enrollment275
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00479505Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive BladderPHASE2 COMPLETED 275 — — Jun 1, 2007Jun 1, 2008Mar 23, 201152 Australia, Canada +14
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Study Endpoints
Primary Endpoints
This is an estimation study with no primary endpoint. There are efficacy endpoints.
12 Weeks
Secondary Endpoints
Patient reported treatment impact questionnaire.
12 Weeks
Lower urinary tract symptoms diary.
12 Weeks
International prostate symptom score questionnaire.
12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
UK-369,003DRUGUK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Male subjects aged 18 years and above * documented clinical diagnosis of overactive bladder with urinary frequency \>= 8 times / 24 hours and number of urgency episodes \> 1 episode / 24 hours. Exclusion Criteria: * Neurological diseases known to affect bladder function. * U...

Countries:AustraliaCanadaChileColombiaFinlandFranceGermanyGreeceItalyLatviaNorwayPolandSlovakiaSpainSwitzerlandUnited Kingdom
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