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alfuzosin

Phase 3

Prostatic Hyperplasia | Small molecule | Other |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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment1,977
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00399464Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic HyperplasiaPHASE3 COMPLETED 1,177Nov 1, 2006Oct 1, 2007Oct 2, 20091 Japan
NCT00290030ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPHPHASE3 COMPLETED 800May 1, 2001Oct 1, 2004Mar 12, 2009 -
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Study Endpoints
Primary Endpoints
Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)
Successful voiding in initial period (using an active voiding trial)
No relapse during the 6 month treatment period
No need / indication for surgery during the initial or 6 month treatment periods
Secondary Endpoints
Efficacy: Change in I-PSS total score from baseline to each visit
Change in Quality Of Life score from baseline to each visit
Change from baseline to endpoint of residual urine volume and urinary Peak Flow
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
alfuzosinDRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Japanese; * Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months; * Suffering for at least 6 months from lower urinary tract symptoms related to BPH. Exclusion Criteria: * Patients with mental disorders or w...

Countries:Japan
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Competitive Landscape -Benign Prostatic Hyperplasia 6 trials