Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms
NCT ID: NCT00463541
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2225 participants
INTERVENTIONAL
2004-06-30
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
solifenacin succinate
oral
Interventions
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solifenacin succinate
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
Exclusion Criteria
* Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
* Clinically significant outflow obstruction (benign prostatic hyperplasia)
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Bay Minette, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Decatur, Alabama, United States
Huntsville, Alabama, United States
Oro Valley, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Buena Park, California, United States
Corte Madera, California, United States
Culver City, California, United States
Fresno, California, United States
Fullerton, California, United States
Huntington Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Modesto, California, United States
Oceanside, California, United States
Orange, California, United States
Orange, California, United States
Paramount, California, United States
Pomona, California, United States
Sacramento, California, United States
San Bernadino, California, United States
San Diego, California, United States
Torrance, California, United States
Tustin, California, United States
Upland, California, United States
Vista, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Fort Collins, Colorado, United States
Wheat Ridge, Colorado, United States
Avon, Connecticut, United States
Hartford, Connecticut, United States
Wilmington, Delaware, United States
Brandon, Florida, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Delray Beach, Florida, United States
Fort Myers, Florida, United States
Ft.Lauderdale, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Merritt Island, Florida, United States
Miami, Florida, United States
Okeechobee, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Royal Palm Beach, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Albany, Georgia, United States
Atlanta, Georgia, United States
Conyers, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
Snellville, Georgia, United States
Woodstock, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Greenville, Illinois, United States
Libertyville, Illinois, United States
Mattoon, Illinois, United States
Park Ridge, Illinois, United States
Indianapolis, Indiana, United States
Mason City, Iowa, United States
Arkansas City, Kansas, United States
Newton, Kansas, United States
Shawnee, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Glen Burnie, Maryland, United States
Milford, Massachusetts, United States
Watertown, Massachusetts, United States
Battle Creek, Michigan, United States
Dearborn, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
Saint Clair Shores, Michigan, United States
Saint Louis Park, Minnesota, United States
Gulfport, Mississippi, United States
Jackson, Mississippi, United States
Independence, Missouri, United States
Jackson, Missouri, United States
Kansas City, Missouri, United States
Liberty, Missouri, United States
Manchester, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Reno, Nevada, United States
East Orange, New Jersey, United States
Englewood, New Jersey, United States
Fair Lawn, New Jersey, United States
New Brunswick, New Jersey, United States
Perth Amboy, New Jersey, United States
Princeton, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Brooklyn, New York, United States
Lake Success, New York, United States
Liverpool, New York, United States
Mineola, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Rochester, New York, United States
Rochester, New York, United States
The Bronx, New York, United States
Asheboro, North Carolina, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Columbus, North Carolina, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
McConnelsville, Ohio, United States
Mentor, Ohio, United States
Painesville, Ohio, United States
Zanesville, Ohio, United States
Norman, Oklahoma, United States
Tulsa, Oklahoma, United States
Tulsa, Oklahoma, United States
Bend, Oregon, United States
Portland, Oregon, United States
Woodburn, Oregon, United States
Allentown, Pennsylvania, United States
Allentown, Pennsylvania, United States
Bala-Cynwyd, Pennsylvania, United States
Beaver, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Bethel Park, Pennsylvania, United States
Camp Hill, Pennsylvania, United States
Dauphin, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Elkins Park, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Williamsport, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Bartlett, Tennessee, United States
Greeneville, Tennessee, United States
Johnson City, Tennessee, United States
Murfreesboro, Tennessee, United States
Nashville, Tennessee, United States
New Tazewell, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Corsicana, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Sandy City, Utah, United States
Charlottesville, Virginia, United States
Hampton, Virginia, United States
Vienna, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Huntington, West Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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905-UC-007
Identifier Type: -
Identifier Source: org_study_id
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