Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms (VOLT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00463541
First received: April 19, 2007
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: solifenacin succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients satisfied with 5mg treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percentage of patients obtaining additional benefit with increase to 10mg dose [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Enrollment: 2225
Study Start Date: June 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: solifenacin succinate
oral
Other Names:
  • VESIcare (R)
  • YM905

Detailed Description:

Study included a 24 week extension that did not occur due to FDA approval of the product.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
  • 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:

  • -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
  • Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
  • Clinically significant outflow obstruction (benign prostatic hyperplasia)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463541

  Hide Study Locations
Locations
United States, Alabama
Bay Minette, Alabama, United States, 35607
Birmingham, Alabama, United States, 35233
Birmingham, Alabama, United States, 35209
Birmingham, Alabama, United States, 35205
Decatur, Alabama, United States, 35603
Huntsville, Alabama, United States, 35801
United States, Arizona
Oro Valley, Arizona, United States, 85739
Phoenix, Arizona, United States, 85012
Phoenix, Arizona, United States, 85051
Scottsdale, Arizona, United States, 85260
Tucson, Arizona, United States, 85712
United States, Arkansas
Little Rock, Arkansas, United States, 72205
Little Rock, Arkansas, United States, 72204
United States, California
Beverly Hills, California, United States, 90211
Buena Park, California, United States, 90620
Corte Madera, California, United States, 94925
Culver City, California, United States, 90232
Fresno, California, United States, 93720
Fullerton, California, United States, 92835
Huntington Beach, California, United States, 92647
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90048
Mission Viejo, California, United States, 92692
Modesto, California, United States, 95350
Oceanside, California, United States, 92056
Orange, California, United States, 92869
Orange, California, United States, 92868
Paramount, California, United States, 90723
Pomona, California, United States, 91767
Sacramento, California, United States, 95823
San Bernadino, California, United States, 92404
San Diego, California, United States, 92108
Torrance, California, United States, 90505
Tustin, California, United States, 92780
Upland, California, United States, 91786
Vista, California, United States, 92084
United States, Colorado
Aurora, Colorado, United States, 80012
Colorado Springs, Colorado, United States, 80909
Fort Collins, Colorado, United States, 80524
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Avon, Connecticut, United States, 06001
Hartford, Connecticut, United States, 06106
United States, Delaware
Wilmington, Delaware, United States, 19808
United States, Florida
Brandon, Florida, United States, 33511
Coral Gables, Florida, United States, 33134
Coral Springs, Florida, United States, 33065
Delray Beach, Florida, United States, 33444
Fort Myers, Florida, United States, 33908
Ft.Lauderdale, Florida, United States, 33308
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32025
Merritt Island, Florida, United States, 32952
Miami, Florida, United States, 33186
Okeechobee, Florida, United States, 34972
Orlando, Florida, United States, 32806
Pembroke Pines, Florida, United States, 33028
Pembroke Pines, Florida, United States, 33026
Pembroke Pines, Florida, United States, 33027
Royal Palm Beach, Florida, United States, 33411
Tampa, Florida, United States, 33624
Wellington, Florida, United States, 33414
United States, Georgia
Albany, Georgia, United States, 31701
Atlanta, Georgia, United States, 30342
Conyers, Georgia, United States, 30013
Decatur, Georgia, United States, 30032
Marietta, Georgia, United States, 30060
Roswell, Georgia, United States, 30076
Snellville, Georgia, United States, 30078
Woodstock, Georgia, United States, 30189
United States, Illinois
Chicago, Illinois, United States, 60628
Chicago, Illinois, United States, 60612
Evanston, Illinois, United States, 60201
Greenville, Illinois, United States, 62246
Libertyville, Illinois, United States, 60048
Mattoon, Illinois, United States, 61938
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indianapolis, Indiana, United States, 46237
United States, Iowa
Mason City, Iowa, United States, 50401
United States, Kansas
Arkansas City, Kansas, United States, 67005
Newton, Kansas, United States, 67114
Shawnee, Kansas, United States, 66203
Topeka, Kansas, United States, 66614
Wichita, Kansas, United States, 67207
United States, Louisiana
New Orleans, Louisiana, United States, 70115
Shreveport, Louisiana, United States, 71106
United States, Maryland
Baltimore, Maryland, United States, 21212
Glen Burnie, Maryland, United States, 21601
United States, Massachusetts
Milford, Massachusetts, United States, 01757
Watertown, Massachusetts, United States, 02472
United States, Michigan
Battle Creek, Michigan, United States, 49017
Dearborn, Michigan, United States, 48123
Detroit, Michigan, United States, 48201
Grand Rapids, Michigan, United States, 49546
Grand Rapids, Michigan, United States, 49544
Kalamazoo, Michigan, United States, 49009
St. Clair Shores, Michigan, United States, 48081
United States, Minnesota
St. Louis Park, Minnesota, United States, 55416
United States, Mississippi
Gulfport, Mississippi, United States, 39501
Jackson, Mississippi, United States, 39202
United States, Missouri
Independence, Missouri, United States, 64055
Jackson, Missouri, United States, 63755
Kansas City, Missouri, United States, 64112
Liberty, Missouri, United States, 64068
Manchester, Missouri, United States, 63021
Springfield, Missouri, United States, 65804
St. Louis, Missouri, United States, 63117
St. Louis, Missouri, United States, 63141
United States, Montana
Missoula, Montana, United States, 59801
United States, Nebraska
Omaha, Nebraska, United States, 68137
Omaha, Nebraska, United States, 68114
Omaha, Nebraska, United States, 68134
United States, Nevada
Henderson, Nevada, United States, 89014
Reno, Nevada, United States, 89511
United States, New Jersey
East Orange, New Jersey, United States, 07018
Englewood, New Jersey, United States, 07631
Fair Lawn, New Jersey, United States, 07410
New Brunswick, New Jersey, United States, 08901
Perth Amboy, New Jersey, United States, 08861
Princeton, New Jersey, United States, 08540
United States, New Mexico
Albuquerque, New Mexico, United States, 87109
Albuquerque, New Mexico, United States, 87108
United States, New York
Albany, New York, United States, 12208
Bronx, New York, United States, 10461
Brooklyn, New York, United States, 11219
Brooklyn, New York, United States, 11203
Lake Success, New York, United States, 11042
Liverpool, New York, United States, 13088
Mineola, New York, United States, 11501
New York, New York, United States, 10021
Poughkeepsie, New York, United States, 12601f
Rochester, New York, United States, 14622
Rochester, New York, United States, 14642
Rochester, New York, United States, 14609
United States, North Carolina
Asheboro, North Carolina, United States, 27205
Cary, North Carolina, United States, 27511
Charlotte, North Carolina, United States, 28204
Charlotte, North Carolina, United States, 28211
Columbus, North Carolina, United States, 28722
Greensboro, North Carolina, United States, 27401
Raleigh, North Carolina, United States, 27606
Raleigh, North Carolina, United States, 27612
United States, Ohio
Canton, Ohio, United States, 44708
Cincinnati, Ohio, United States, 45236
Cleveland, Ohio, United States, 44113
McConnelsville, Ohio, United States, 43756
Mentor, Ohio, United States, 44060
Painesville, Ohio, United States, 44077
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Norman, Oklahoma, United States, 73071
Tulsa, Oklahoma, United States, 74104
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Bend, Oregon, United States, 97701
Portland, Oregon, United States, 97210
Woodburn, Oregon, United States, 97071
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18104
Allentown, Pennsylvania, United States, 18102
Bala Cynwyd, Pennsylvania, United States, 19004
Beaver, Pennsylvania, United States, 15009
Bensalem, Pennsylvania, United States, 19020
Bethel Park, Pennsylvania, United States, 15102
Camp Hill, Pennsylvania, United States, 17011
Dauphin, Pennsylvania, United States, 17018
Duncansville, Pennsylvania, United States, 16635
Elkins Park, Pennsylvania, United States, 19027
Harrisburg, Pennsylvania, United States, 17110
Philadelphia, Pennsylvania, United States, 19140
Philadelphia, Pennsylvania, United States, 19114
Phoenixville, Pennsylvania, United States, 19460
Pittsburgh, Pennsylvania, United States, 15206
Williamsport, Pennsylvania, United States, 17701
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Bartlett, Tennessee, United States, 38134
Greeneville, Tennessee, United States, 37745
Johnson City, Tennessee, United States, 37601
Murfreesboro, Tennessee, United States, 37130
Nashville, Tennessee, United States, 37203
New Tazewell, Tennessee, United States, 37825
United States, Texas
Austin, Texas, United States, 78759
Austin, Texas, United States, 78705
Corsicana, Texas, United States, 75110
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75231
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77024
Houston, Texas, United States, 77074
Plano, Texas, United States, 75093
San Antonio, Texas, United States, 78229
Tomball, Texas, United States, 77375
United States, Utah
Salt Lake City, Utah, United States, 84107
Sandy, Utah, United States, 84094
United States, Virginia
Charlottesville, Virginia, United States, 22908
Hampton, Virginia, United States, 23666
Vienna, Virginia, United States, 22180
United States, Washington
Seattle, Washington, United States, 98133
Spokane, Washington, United States, 99204
Tacoma, Washington, United States, 98450
United States, West Virginia
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00463541     History of Changes
Other Study ID Numbers: 905-UC-007
Study First Received: April 19, 2007
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Urinary Bladder, Overactive
Urgency
VESIcare®
Solifenacin succinate

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Solifenacin
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 23, 2014