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Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder | Clinical Trials | Clareo Health

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Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US

NCT00454740•Astellas Pharma Inc

View on ClinicalTrials.gov

Summary

To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.
•Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.
•At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.
•Prior to treatment with tolterodine tartrate extended release, patients must have had OAB syndrome for 3 or more months.

Exclusion Criteria

•Previous treatment with darifenacin
•Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.
•Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
•Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones.
•Clinically significant outflow obstruction as determined by the Investigator
•Uncontrolled narrow angle glaucoma, urinary or gastric retention.
•All patients with severe renal or hepatic impairment will be excluded
•Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

Locations (104)

Anchorage, Alaska, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Little Rock, Arkansas, United States

Dinuba, California, United States

Glendora, California, United States

La Mesa, California, United States

Los Angeles, California, United States

Key Dates

Start Date

June 1, 2004

Primary Completion Date

August 1, 2005

Completion Date

August 1, 2005

Last Updated

September 18, 2014

Enrollment

441

ACTUAL participants

Conditions

Urinary Bladder, Overactive

Interventions

solifenacin succinate

DRUG

Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder

NCT07366918

Urinary Bladder, Overactive

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RECRUITING

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

NCT06933407

Urinary IncontinenceUrinary Incontinence, Stress+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

Inclusion Criteria

Exclusion Criteria

Comparison of the Efficacy of Perineal and Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

NXT Post-Market Clinical Follow-up

Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug

A Study of YM178 in Subjects With Symptoms of Overactive Bladder