Back to resultsA Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men. (VICTOR)
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
solifenacin succinate
tamsulosin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Treatment Outcome, Urology, Solifenacin succinate, Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: Symptoms of Overactive Bladder (OAB) Exclusion Criteria: Current use of antimuscarinic therapy Evidence of a urinary tract infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Change in micturitions per 24 hours from baseline to end of treatment
Secondary Outcome Measures
Change in urgency episodes per 24 hours from baseline to end of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00333112
Brief Title
A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.
Acronym
VICTOR
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Safety and Efficacy, Phase 4 Study of VESIcare® (Solifenacin Succinate) or Placebo in Combination With Tamsulosin HCl for the Treatment of Residual OAB Symptoms of Urgency and Frequency in Men VICTOR: VESIcare® In Combination With Tamsulosin in OAB Residual Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
Detailed Description
A 2 arm study ( 1 Active, 1 Placebo) to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Treatment Outcome, Urology, Solifenacin succinate, Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
398 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
solifenacin succinate
Other Intervention Name(s)
Vesicare®, YM905
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
tamsulosin
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change in micturitions per 24 hours from baseline to end of treatment
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Change in urgency episodes per 24 hours from baseline to end of treatment
Time Frame
18 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptoms of Overactive Bladder (OAB)
Exclusion Criteria:
Current use of antimuscarinic therapy
Evidence of a urinary tract infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astellas US Medical Information
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Buena Park
State/Province
California
ZIP/Postal Code
90320
Country
United States
City
Buena
State/Province
California
ZIP/Postal Code
90620
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Culver City
State/Province
California
ZIP/Postal Code
90232
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Mission Hills
State/Province
California
ZIP/Postal Code
92084
Country
United States
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49544
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
City
Mountain Lake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19837435
Citation
Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140594 in the JapicCTI-RNo. field
Learn more about this trial
A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.
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