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UK0369,003

Phase 2

Impotence | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 25, 2006

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00174486Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile DysfunctionPHASE2 COMPLETED 300Feb 1, 2005Jun 1, 2005Jul 25, 2006 -
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Study Endpoints
Primary Endpoints
Assessment of duration of action, safety & toleration of the investigational drug and Cialis
Secondary Endpoints
Assess safety & toleration over 4 week treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
UK0369,003DRUG -
Cialis (Tadalafil)DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersNo

Inclusion Criteria: * Erectile Dysfunction Exclusion Criteria: * Alpha blockers and Nitrates of any preparation

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