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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).
Study included a 24 week extension that did not occur due to FDA approval of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solifenacin succinate | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms | Weeks 4, 8 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients satisfied with 5mg treatment | Week 12 | |
| Percentage of patients obtaining additional benefit with increase to 10mg dose | week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay Minette | Alabama | 35607 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18036164 | Background | Capo' JP Jr, Laramee C, Lucente V, Fakhoury A, Forero-Schwanhaeuser S. Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare Open-Label Trial. Int J Clin Pract. 2008 Jan;62(1):39-46. doi: 10.1111/j.1742-1241.2007.01644.x. Epub 2007 Nov 23. | |
| 17407639 |
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| Birmingham |
| Alabama |
| 35205 |
| United States |
| Birmingham | Alabama | 35209 | United States |
| Birmingham | Alabama | 35233 | United States |
| Decatur | Alabama | 35603 | United States |
| Huntsville | Alabama | 35801 | United States |
| Oro Valley | Arizona | 85739 | United States |
| Phoenix | Arizona | 85012 | United States |
| Phoenix | Arizona | 85051 | United States |
| Scottsdale | Arizona | 85260 | United States |
| Tucson | Arizona | 85712 | United States |
| Little Rock | Arkansas | 72204 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Beverly Hills | California | 90211 | United States |
| Buena Park | California | 90620 | United States |
| Corte Madera | California | 94925 | United States |
| Culver City | California | 90232 | United States |
| Fresno | California | 93720 | United States |
| Fullerton | California | 92835 | United States |
| Huntington Beach | California | 92647 | United States |
| Long Beach | California | 90806 | United States |
| Los Angeles | California | 90048 | United States |
| Mission Viejo | California | 92692 | United States |
| Modesto | California | 95350 | United States |
| Oceanside | California | 92056 | United States |
| Orange | California | 92868 | United States |
| Orange | California | 92869 | United States |
| Paramount | California | 90723 | United States |
| Pomona | California | 91767 | United States |
| Sacramento | California | 95823 | United States |
| San Bernadino | California | 92404 | United States |
| San Diego | California | 92108 | United States |
| Torrance | California | 90505 | United States |
| Tustin | California | 92780 | United States |
| Upland | California | 91786 | United States |
| Vista | California | 92084 | United States |
| Aurora | Colorado | 80012 | United States |
| Colorado Springs | Colorado | 80909 | United States |
| Fort Collins | Colorado | 80524 | United States |
| Wheat Ridge | Colorado | 80033 | United States |
| Avon | Connecticut | 06001 | United States |
| Hartford | Connecticut | 06106 | United States |
| Wilmington | Delaware | 19808 | United States |
| Brandon | Florida | 33511 | United States |
| Coral Gables | Florida | 33134 | United States |
| Coral Springs | Florida | 33065 | United States |
| Delray Beach | Florida | 33444 | United States |
| Fort Myers | Florida | 33908 | United States |
| Ft.Lauderdale | Florida | 33308 | United States |
| Hollywood | Florida | 33021 | United States |
| Jacksonville | Florida | 32025 | United States |
| Merritt Island | Florida | 32952 | United States |
| Miami | Florida | 33186 | United States |
| Okeechobee | Florida | 34972 | United States |
| Orlando | Florida | 32806 | United States |
| Pembroke Pines | Florida | 33026 | United States |
| Pembroke Pines | Florida | 33027 | United States |
| Pembroke Pines | Florida | 33028 | United States |
| Royal Palm Beach | Florida | 33411 | United States |
| Tampa | Florida | 33624 | United States |
| Wellington | Florida | 33414 | United States |
| Albany | Georgia | 31701 | United States |
| Atlanta | Georgia | 30342 | United States |
| Conyers | Georgia | 30013 | United States |
| Decatur | Georgia | 30032 | United States |
| Marietta | Georgia | 30060 | United States |
| Roswell | Georgia | 30076 | United States |
| Snellville | Georgia | 30078 | United States |
| Woodstock | Georgia | 30189 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60628 | United States |
| Evanston | Illinois | 60201 | United States |
| Greenville | Illinois | 62246 | United States |
| Libertyville | Illinois | 60048 | United States |
| Mattoon | Illinois | 61938 | United States |
| Park Ridge | Illinois | 60068 | United States |
| Indianapolis | Indiana | 46237 | United States |
| Mason City | Iowa | 50401 | United States |
| Arkansas City | Kansas | 67005 | United States |
| Newton | Kansas | 67114 | United States |
| Shawnee | Kansas | 66203 | United States |
| Topeka | Kansas | 66614 | United States |
| Wichita | Kansas | 67207 | United States |
| New Orleans | Louisiana | 70115 | United States |
| Shreveport | Louisiana | 71106 | United States |
| Baltimore | Maryland | 21212 | United States |
| Glen Burnie | Maryland | 21601 | United States |
| Milford | Massachusetts | 01757 | United States |
| Watertown | Massachusetts | 02472 | United States |
| Battle Creek | Michigan | 49017 | United States |
| Dearborn | Michigan | 48123 | United States |
| Detroit | Michigan | 48201 | United States |
| Grand Rapids | Michigan | 49544 | United States |
| Grand Rapids | Michigan | 49546 | United States |
| Kalamazoo | Michigan | 49009 | United States |
| Saint Clair Shores | Michigan | 48081 | United States |
| Saint Louis Park | Minnesota | 55416 | United States |
| Gulfport | Mississippi | 39501 | United States |
| Jackson | Mississippi | 39202 | United States |
| Independence | Missouri | 64055 | United States |
| Jackson | Missouri | 63755 | United States |
| Kansas City | Missouri | 64112 | United States |
| Liberty | Missouri | 64068 | United States |
| Manchester | Missouri | 63021 | United States |
| Springfield | Missouri | 65804 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63141 | United States |
| Missoula | Montana | 59801 | United States |
| Omaha | Nebraska | 68114 | United States |
| Omaha | Nebraska | 68134 | United States |
| Omaha | Nebraska | 68137 | United States |
| Henderson | Nevada | 89014 | United States |
| Reno | Nevada | 89511 | United States |
| East Orange | New Jersey | 07018 | United States |
| Englewood | New Jersey | 07631 | United States |
| Fair Lawn | New Jersey | 07410 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Perth Amboy | New Jersey | 08861 | United States |
| Princeton | New Jersey | 08540 | United States |
| Albuquerque | New Mexico | 87108 | United States |
| Albuquerque | New Mexico | 87109 | United States |
| Albany | New York | 12208 | United States |
| Brooklyn | New York | 11203 | United States |
| Brooklyn | New York | 11219 | United States |
| Lake Success | New York | 11042 | United States |
| Liverpool | New York | 13088 | United States |
| Mineola | New York | 11501 | United States |
| New York | New York | 10021 | United States |
| Poughkeepsie | New York | 12601f | United States |
| Rochester | New York | 14609 | United States |
| Rochester | New York | 14622 | United States |
| Rochester | New York | 14642 | United States |
| The Bronx | New York | 10461 | United States |
| Asheboro | North Carolina | 27205 | United States |
| Cary | North Carolina | 27511 | United States |
| Charlotte | North Carolina | 28204 | United States |
| Charlotte | North Carolina | 28211 | United States |
| Columbus | North Carolina | 28722 | United States |
| Greensboro | North Carolina | 27401 | United States |
| Raleigh | North Carolina | 27606 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Canton | Ohio | 44708 | United States |
| Cincinnati | Ohio | 45236 | United States |
| Cleveland | Ohio | 44113 | United States |
| McConnelsville | Ohio | 43756 | United States |
| Mentor | Ohio | 44060 | United States |
| Painesville | Ohio | 44077 | United States |
| Zanesville | Ohio | 43701 | United States |
| Norman | Oklahoma | 73071 | United States |
| Tulsa | Oklahoma | 74104 | United States |
| Tulsa | Oklahoma | 74146 | United States |
| Bend | Oregon | 97701 | United States |
| Portland | Oregon | 97210 | United States |
| Woodburn | Oregon | 97071 | United States |
| Allentown | Pennsylvania | 18102 | United States |
| Allentown | Pennsylvania | 18104 | United States |
| Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Bensalem | Pennsylvania | 19020 | United States |
| Bethel Park | Pennsylvania | 15102 | United States |
| Camp Hill | Pennsylvania | 17011 | United States |
| Dauphin | Pennsylvania | 17018 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Elkins Park | Pennsylvania | 19027 | United States |
| Harrisburg | Pennsylvania | 17110 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Phoenixville | Pennsylvania | 19460 | United States |
| Pittsburgh | Pennsylvania | 15206 | United States |
| Williamsport | Pennsylvania | 17701 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Bartlett | Tennessee | 38134 | United States |
| Greeneville | Tennessee | 37745 | United States |
| Johnson City | Tennessee | 37601 | United States |
| Murfreesboro | Tennessee | 37130 | United States |
| Nashville | Tennessee | 37203 | United States |
| New Tazewell | Tennessee | 37825 | United States |
| Austin | Texas | 78705 | United States |
| Austin | Texas | 78759 | United States |
| Corsicana | Texas | 75110 | United States |
| Dallas | Texas | 75230 | United States |
| Dallas | Texas | 75231 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77024 | United States |
| Houston | Texas | 77074 | United States |
| Plano | Texas | 75093 | United States |
| San Antonio | Texas | 78229 | United States |
| Tomball | Texas | 77375 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Sandy City | Utah | 84094 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Hampton | Virginia | 23666 | United States |
| Vienna | Virginia | 22180 | United States |
| Seattle | Washington | 98133 | United States |
| Spokane | Washington | 99204 | United States |
| Tacoma | Washington | 98450 | United States |
| Huntington | West Virginia | 25701 | United States |
| Mallett V, Burks D, Garely AD, Smith N. Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes. Curr Med Res Opin. 2007 Apr;23(4):821-31. doi: 10.1185/030079907x178847. |
| 17213014 | Background | Garely AD, Kaufman JM, Sand PK, Smith N, Andoh M. Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther. 2006 Nov;28(11):1935-46. doi: 10.1016/j.clinthera.2006.11.010. |
| 17341526 | Background | Garely AD, Lucente V, Vapnek J, Smith N. Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes. Ann Pharmacother. 2007 Mar;41(3):391-8. doi: 10.1345/aph.1H581. Epub 2007 Mar 6. |
| 19434385 | Background | Sand PK, Steers WD, Dmochowski R, Andoh M, Forero-Schwanhaeuser S. Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):667-75. doi: 10.1007/s00192-009-0840-y. Epub 2009 Mar 10. |
| 21293089 | Derived | 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. |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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