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MK-0634

Phase 2

Urinary Incontinence | Small molecule | Nephrology |Merck & Company, Inc.|Last Updated: Dec 17, 2015

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_CONTROLLED
Total Trials1
Total Enrollment848
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00231790A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)PHASE2 COMPLETED 848 — — Aug 1, 2005Oct 1, 2006Dec 17, 2015 - —
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Study Endpoints
Primary Endpoints
Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days)
Baseline and Week 8
Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)
Day 1 of Follow-up
Proportion of participants with abnormal visual field test (Follow-up Study 007 only)
Day 1 of Follow-up
Secondary Endpoints
Change from baseline in the number of total incontinence episodes
Baseline and Week 8
Number of urge-incontinence episodes
Up to 8 weeks
Number of urgency episodes per day averaged over a diary card week (4 to 10 days)
up to 8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-0634 50 mgEXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
MK-0634 125 mgEXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
MK-0634 375 mgEXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
PlaceboPLACEBO_COMPARATORAll participants will receive placebo for the 1 week prior to randomization
Interventions
NameTypeDescription
MK-0634 50 mgDRUGone capsule orally, once daily in morning
MK-0634 125 mgDRUGone or three capsules orally, once daily in morning
Placebo for MK-0634DRUGone, two, three or four capsules orally once daily in morning
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Eligibility Criteria
Age Range40 Years — 74 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Postmenopausal females (ages 40-74) with predominantly urge urinary incontinence overactive bladder episodes. * Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards. Exclusion Criteria: * Patients must ...

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