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Tamsulosin

Phase 3

Benign Prostatic Hyperplasia | Small molecule | Nephrology |Eli Lilly and Company|Last Updated: Jun 28, 2011

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment763
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00861757Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic HyperplasiaPHASE3 COMPLETED 612 — — Mar 1, 2009Jun 1, 2010Jun 28, 20116 Japan, Taiwan
NCT00540124Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian MenPHASE2 COMPLETED 151 — — Oct 1, 2007Jun 1, 2008Nov 25, 20105 South Korea
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Study Endpoints
Primary Endpoints
Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
baseline, 12 weeks

The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.

Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
baseline, 12 weeks

The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

Secondary Endpoints
Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])
baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks
baseline, 12 weeks
Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks
baseline, 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
2.5 mg TadalafilEXPERIMENTAL -
5.0 mg TadalafilEXPERIMENTAL -
0.2 mg TamsulosinACTIVE_COMPARATOR -
TadalafilEXPERIMENTAL -
TamsulosinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
TadalafilDRUGby mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
PlaceboDRUGPO, QD (30 min after meal) for 12 weeks
TamsulosinDRUGPO, QD (30 min after meal) for 12 weeks
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Eligibility Criteria
Age Range45 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment * Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and ov...

Countries:JapanTaiwanSouth Korea
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Competitive Landscape -Benign Prostatic Hyperplasia 6 trials
CompanyTickerTrialsLead PhaseDrugs
Boston Scientific CorporationBSX2 — Undisclosed
PROCEPT BioRobotics Corp.PRCT2NAUndisclosed
EDAP TMS SA Sponsored ADREDAP1NAUndisclosed
Profound Medical CorpPROF1 — Undisclosed
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