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propiverine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

propiverine · 1 trial · 1 indication

Phase 3 1
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 MonitoringUrinary Bladder, Overactive
COMPLETED41 Analytics
PHASE3COMPLETED
A 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 Monitoring
Urinary Bladder, OveractiveUnlock trial analytics

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 to 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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Frequently asked questions about propiverine

What is propiverine used for?

Propiverine is an investigational small molecule being studied for the treatment of overactive bladder. It is in Phase 3 clinical development and has been evaluated in a completed clinical trial for this condition.

Who is developing propiverine?

Propiverine is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical development for overactive bladder.

What phase is propiverine in?

Propiverine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 clinical trial for propiverine has been completed.

What clinical trials is propiverine in?

Propiverine has been studied in a completed Phase 3 clinical trial registered as NCT00646880. This trial evaluated the efficacy of propiverine compared with tolterodine prolonged release in Korean patients with overactive bladder, using ambulatory urodynamic monitoring.

Is propiverine the same as tolterodine?

Propiverine is not the same as tolterodine. In a completed Phase 3 clinical trial, propiverine was compared with tolterodine prolonged release as an active control for the treatment of overactive bladder in Korean patients.