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propiverine

Phase 3

Urinary Bladder, Overactive | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Mar 31, 2008

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00646880A Study to Evaluate the Efficacy of Tolterodine Prolonged Release Compared With Propiverine for the Treatment of Korean Patients With Overactive Bladder as Assessed by Ambulatory Urodynamic MonitoringPHASE3 COMPLETED 41Mar 1, 2003Aug 1, 2003Mar 31, 20081 South Korea
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Study Endpoints
Primary Endpoints
Parameters of detrusor activity, occurring throughout the duration of comparable AUM
28 days
Secondary Endpoints
Number of pads used per 24 hours
28 days
Urge Incontinence
28 days
Number of urgency episodes
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Propiverine/tolterodine groupACTIVE_COMPARATOR -
Tolerodine/propiverine groupACTIVE_COMPARATOR -
Interventions
NameTypeDescription
propiverineDRUGTwo week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week.
tolterodine PRDRUGTwo week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week.
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Symptoms of urinary urgency * Symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart * Symptoms of overactive bladder for greater than or equal to 6 months Exclusion Criteria: * Stress incontinence ...

Countries:South Korea
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