Status:
COMPLETED
Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).
Detailed Description
Study included a 24 week extension that did not occur due to FDA approval of the product.
Eligibility Criteria
Inclusion
- Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
- Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
Exclusion
- -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction (benign prostatic hyperplasia)
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
2225 Patients enrolled
Trial Details
Trial ID
NCT00463541
Start Date
June 1 2004
End Date
April 1 2005
Last Update
September 18 2014
Active Locations (198)
Enter a location and click search to find clinical trials sorted by distance.
1
Bay Minette, Alabama, United States, 35607
2
Birmingham, Alabama, United States, 35205
3
Birmingham, Alabama, United States, 35209
4
Birmingham, Alabama, United States, 35233