Status:
COMPLETED
Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT00454740
Start Date
June 1 2004
End Date
August 1 2005
Last Update
September 18 2014
Active Locations (104)
Enter a location and click search to find clinical trials sorted by distance.
1
Anchorage, Alaska, United States, 99508
2
Phoenix, Arizona, United States, 85032
3
Scottsdale, Arizona, United States, 85258
4
Little Rock, Arkansas, United States, 72211