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afuzosin

Phase 3

Benign Prostatic Hyperplasia | Small molecule | Nephrology |Sanofi|Last Updated: Oct 2, 2009

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
UNCONTROLLED
Total Trials1
Total Enrollment148
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00347061Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPHPHASE3 COMPLETED 148May 1, 2006Oct 1, 2007Oct 2, 20091 Japan
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Study Endpoints
Primary Endpoints
One year safety data of SL77.0499-10
Secondary Endpoints
One year efficacy data and plasma concentration of SL77.0499-10
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
afuzosinDRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography * Suffering for at least 6 months from lower urinary tract symptoms related to BPH * An I-PSS total score ≥ 13 * Out patient Exclusion Criteria: * Patients previously treated with...

Countries:Japan
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Competitive Landscape -Benign Prostatic Hyperplasia 6 trials