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SL77.0499-10

Phase 2

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment473
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00409357Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic HyperplasiaPHASE2 COMPLETED 473Nov 1, 2004Aug 1, 2005Oct 2, 20091 Japan
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Study Endpoints
Primary Endpoints
The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.
Secondary Endpoints
Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit.
Safety: adverse events, vital signs, laboratory tests.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SL77.0499-10 (alfuzosin hydrochloride)DRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * suffering from LUTS related to BPH for at least 6 months; * having an IPSS \>13; * having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL; * having a residual urine volume \< or = 200 mL.

Countries:Japan
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Competitive Landscape -Benign Prostatic Hyperplasia 6 trials