Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder (VERSUS)
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
solifenacin succinate
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome.
Secondary Outcome Measures
To assess the improvement in urge incontinence, frequency,nocturia, and urgency
Number of patients satisfied with treatment
Assessment of efficacy
Evaluation of the safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00454740
Brief Title
Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder
Acronym
VERSUS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
441 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
solifenacin succinate
Other Intervention Name(s)
VESIcare(R), YM905
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome.
Time Frame
Weeks 1, 4, 8 and 12
Secondary Outcome Measure Information:
Title
To assess the improvement in urge incontinence, frequency,nocturia, and urgency
Time Frame
Weeks 1, 4, 8 and 12
Title
Number of patients satisfied with treatment
Time Frame
Weeks 1, 4, 8 and 12
Title
Assessment of efficacy
Time Frame
End of study
Title
Evaluation of the safety and tolerability
Time Frame
Baseline to end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Anchorage
State/Province
Alaska
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99508
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United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
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United States
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Scottsdale
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Arizona
ZIP/Postal Code
85258
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United States
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Little Rock
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Arkansas
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72211
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United States
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Dinuba
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California
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93618
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United States
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Glendora
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California
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91741
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United States
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La Mesa
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California
ZIP/Postal Code
91942
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United States
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Los Angeles
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California
ZIP/Postal Code
90017
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United States
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Los Angeles
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California
ZIP/Postal Code
90048
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United States
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Los Angeles
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California
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90057
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United States
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Mission Hills
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California
ZIP/Postal Code
91345
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United States
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Modesto
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California
ZIP/Postal Code
95350
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United States
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San Bernadino
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California
ZIP/Postal Code
92404
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United States
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Torrance
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California
ZIP/Postal Code
90505
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United States
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Upland
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California
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91786
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United States
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Valley Village
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California
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91607
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United States
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Aurora
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Colorado
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80012
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United States
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Denver
State/Province
Colorado
ZIP/Postal Code
80205
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United States
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Denver
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Colorado
ZIP/Postal Code
80220
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United States
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Farmington
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Connecticut
ZIP/Postal Code
06302
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United States
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Norwalk
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Connecticut
ZIP/Postal Code
06850
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United States
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Trumbull
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Connecticut
ZIP/Postal Code
06611
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United States
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Waterbury
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Connecticut
ZIP/Postal Code
06708
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United States
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Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
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United States
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Aventura
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Florida
ZIP/Postal Code
33180
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United States
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Clearwater
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Florida
ZIP/Postal Code
33761
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United States
City
Clearwater
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Florida
ZIP/Postal Code
33765
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United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
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United States
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Gainesville
State/Province
Florida
ZIP/Postal Code
32607
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United States
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Margate
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Florida
ZIP/Postal Code
33063
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United States
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New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
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United States
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Orange City
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Florida
ZIP/Postal Code
32763
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United States
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Orlando
State/Province
Florida
ZIP/Postal Code
32803
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United States
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St Augustine
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Florida
ZIP/Postal Code
32086
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United States
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Tallahassee
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Florida
ZIP/Postal Code
32308
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United States
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Alpharetta
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Georgia
ZIP/Postal Code
30005
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United States
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Atlanta
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Georgia
ZIP/Postal Code
30342
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United States
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Blue Ridge
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Georgia
ZIP/Postal Code
30513
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United States
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Boise
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Idaho
ZIP/Postal Code
83702
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United States
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Coeur d'Alene
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Idaho
ZIP/Postal Code
83814
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United States
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Centralia
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Illinois
ZIP/Postal Code
62801
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Chicago
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Illinois
ZIP/Postal Code
60616
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United States
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Kankakee
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Illinois
ZIP/Postal Code
60901
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United States
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Niles
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Illinois
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60714
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United States
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Evansville
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Indiana
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47714
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United States
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Indianapolis
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Indiana
ZIP/Postal Code
46202
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United States
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Jeffersonville
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Indiana
ZIP/Postal Code
47130
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United States
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Muncie
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Indiana
ZIP/Postal Code
47303
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21204
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United States
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Garrison
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Maryland
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21117
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United States
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St Louis
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Missouri
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63117
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United States
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St Louis
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Missouri
ZIP/Postal Code
63141
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United States
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Las Vegas
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Nevada
ZIP/Postal Code
89109
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United States
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Edison
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New Jersey
ZIP/Postal Code
08837
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United States
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Lawrenceville
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New Jersey
ZIP/Postal Code
08648
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United States
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Neptune
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New Jersey
ZIP/Postal Code
07753
Country
United States
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West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
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United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
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United States
City
Albany
State/Province
New York
ZIP/Postal Code
12206
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United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Bayshore
State/Province
New York
ZIP/Postal Code
11706
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United States
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Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
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Garden City
State/Province
New York
ZIP/Postal Code
11530
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United States
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Lewiston
State/Province
New York
ZIP/Postal Code
14092
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97411
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
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United States
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18760
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United States
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
19406
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
Jefferson City
State/Province
Tennessee
ZIP/Postal Code
37760
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
City
Athens
State/Province
Texas
ZIP/Postal Code
75751
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
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United States
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
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United States
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
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United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
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United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
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Richmond
State/Province
Virginia
ZIP/Postal Code
23294
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United States
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Seattle
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Washington
ZIP/Postal Code
98111
Country
United States
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Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19014833
Citation
Chancellor MB, Zinner N, Whitmore K, Kobashi K, Snyder JA, Siami P, Karram M, Laramee C, Capo' JP Jr, Seifeldin R, Forero-Schwanhaeuser S, Nandy I. Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: results of a 12-week, multicenter, open-label, flexible-dose study. Clin Ther. 2008 Oct;30(10):1766-81. doi: 10.1016/j.clinthera.2008.10.011.
Results Reference
background
PubMed Identifier
18423103
Citation
Zinner N, Noe L, Rasouliyan L, Marshall T, Seifeldin R. Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER. Curr Med Res Opin. 2008 Jun;24(6):1583-91. doi: 10.1185/03007990802081766. Epub 2008 Apr 17.
Results Reference
background
PubMed Identifier
19366272
Citation
Swift SE, Siami P, Forero-Schwanhaeuser S. Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4 mg/day to solifenacin treatment: An open-label, flexible-dosing, multicentre study. Clin Drug Investig. 2009;29(5):305-16. doi: 10.2165/00044011-200929050-00003.
Results Reference
background
PubMed Identifier
20129258
Citation
Zinner N, Noe L, Rasouliyan L, Marshall T, Runken MC, Seifeldin R. Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis. Am J Geriatr Pharmacother. 2009 Dec;7(6):373-82. doi: 10.1016/j.amjopharm.2009.11.004.
Results Reference
background
PubMed Identifier
21293089
Citation
Capo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged >/= 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140592 in the JapicCTI-RNo. field
Learn more about this trial
Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder
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