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PF-00592379

Phase 2

Impotence | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 24, 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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00273416A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral DosesPHASE2 COMPLETED 32 — — Jan 1, 2006 -Aug 24, 20062 Norway, United Kingdom
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Study Endpoints
Primary Endpoints
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Secondary Endpoints
Duration and quality of penile erections recorded in a self-assessment diary.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
PF-00592379DRUG -
Sildenafil 100mgDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction. Exclusion Criteria: * Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not. * Patients on nitrates or alpha...

Countries:NorwayUnited Kingdom
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