VICTOR: A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.
Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00333112
Collaborator
(none)
398
74
2
8
5.4
0.7
Study Details
Study Description
Brief Summary
A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Study Design
Study Type:
Interventional
Actual Enrollment
:
398 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
May 1, 2006
Actual Primary Completion Date
:
Jan 1, 2007
Actual Study Completion Date
:
Jan 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: solifenacin succinate
Oral
Other Names:
Drug: tamsulosin
oral
|
| Placebo Comparator: 2
|
Drug: tamsulosin
oral
Drug: placebo
oral
|
Outcome Measures
Primary Outcome Measures
- Change in micturitions per 24 hours from baseline to end of treatment [18 weeks]
Secondary Outcome Measures
- Change in urgency episodes per 24 hours from baseline to end of treatment [18 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Symptoms of Overactive Bladder (OAB)
Exclusion Criteria:
-
Current use of antimuscarinic therapy
-
Evidence of a urinary tract infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35209 | |
| 2 | Phoenix | Arizona | United States | 85050 | |
| 3 | Tuscon | Arizona | United States | 85712 | |
| 4 | Atherton | California | United States | 94027 | |
| 5 | Beverly Hills | California | United States | 90211 | |
| 6 | Buena Park | California | United States | 90320 | |
| 7 | Buena | California | United States | 90620 | |
| 8 | Carmichael | California | United States | 95608 | |
| 9 | Culver City | California | United States | 90232 | |
| 10 | Fresno | California | United States | 93720 | |
| 11 | Mission Hills | California | United States | 92084 | |
| 12 | Modesto | California | United States | 95350 | |
| 13 | Orange | California | United States | 92869 | |
| 14 | San Bernardino | California | United States | 92404 | |
| 15 | San Diego | California | United States | 92108 | |
| 16 | Torrance | California | United States | 90505 | |
| 17 | Aurora | Colorado | United States | 80012 | |
| 18 | Denver | Colorado | United States | 80210 | |
| 19 | Wheat Ridge | Colorado | United States | 80033 | |
| 20 | Danbury | Connecticut | United States | 06708 | |
| 21 | Clearwater | Florida | United States | 33761 | |
| 22 | Daytona Beach | Florida | United States | 32114 | |
| 23 | Fort Myers | Florida | United States | 33908 | |
| 24 | New Port Richey | Florida | United States | 34652 | |
| 25 | Orlando | Florida | United States | 32803 | |
| 26 | Orlando | Florida | United States | 32806 | |
| 27 | Pembroke Pines | Florida | United States | 33027 | |
| 28 | Pembroke Pines | Florida | United States | 33028 | |
| 29 | Tallahassee | Florida | United States | 32308 | |
| 30 | Wellington | Florida | United States | 33414 | |
| 31 | Atlanta | Georgia | United States | 30342 | |
| 32 | Blue Ridge | Georgia | United States | 30513 | |
| 33 | Marietta | Georgia | United States | 30060 | |
| 34 | Roswell | Georgia | United States | 30076 | |
| 35 | Sandy Springs | Georgia | United States | 30328 | |
| 36 | Snellville | Georgia | United States | 30078 | |
| 37 | Coeur d'Alene | Idaho | United States | 83814 | |
| 38 | Evansville | Indiana | United States | 47714 | |
| 39 | Wichita | Kansas | United States | 67207 | |
| 40 | Shreveport | Louisiana | United States | 71106 | |
| 41 | Boston | Massachusetts | United States | 02115 | |
| 42 | Watertown | Massachusetts | United States | 02472 | |
| 43 | Grand Rapids | Michigan | United States | 49544 | |
| 44 | Jackson | Mississippi | United States | 39202 | |
| 45 | West Orange | New Jersey | United States | 07052 | |
| 46 | Endwell | New York | United States | 13760 | |
| 47 | Garden City | New York | United States | 11530 | |
| 48 | New York | New York | United States | 10016 | |
| 49 | New York | New York | United States | 10021 | |
| 50 | Orchard Park | New York | United States | 14127 | |
| 51 | Poughkeepsie | New York | United States | 12601 | |
| 52 | Rochester | New York | United States | 14642 | |
| 53 | Concord | North Carolina | United States | 28025 | |
| 54 | Hickory | North Carolina | United States | 28601 | |
| 55 | Winston Salem | North Carolina | United States | 27103 | |
| 56 | Cincinnati | Ohio | United States | 45212 | |
| 57 | Cincinnati | Ohio | United States | 45249 | |
| 58 | Bethany | Oklahoma | United States | 73008 | |
| 59 | Norman | Oklahoma | United States | 73071 | |
| 60 | Springfield | Oregon | United States | 97477 | |
| 61 | Bala Cynwyd | Pennsylvania | United States | 19004 | |
| 62 | Bensalem | Pennsylvania | United States | 19020 | |
| 63 | Camp Hill | Pennsylvania | United States | 17011 | |
| 64 | Lancaster | Pennsylvania | United States | 17604 | |
| 65 | Uniontown | Pennsylvania | United States | 15401 | |
| 66 | Mt. Pleasant | South Carolina | United States | 29464 | |
| 67 | Simpsonville | South Carolina | United States | 29681 | |
| 68 | Nashville | Tennessee | United States | 37203 | |
| 69 | Houston | Texas | United States | 77024 | |
| 70 | Ogden | Utah | United States | 84403 | |
| 71 | Salt Lake City | Utah | United States | 84121 | |
| 72 | Virginia Beach | Virginia | United States | 23454 | |
| 73 | Mountain Lake Terrace | Washington | United States | 98043 | |
| 74 | Spokane | Washington | United States | 99202 |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
- Study Director: Astellas US Medical Information, Astellas Pharma US, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
Responsible Party:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00333112
Other Study ID Numbers:
- 905-UC-008
First Posted:
Jun 2, 2006
Last Update Posted:
Sep 18, 2014
Last Verified:
Sep 1, 2014
Keywords provided by Astellas Pharma Inc
Additional relevant MeSH terms: