A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men. (VICTOR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00333112
First received: June 1, 2006
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.


Condition Intervention Phase
Urinary Incontinence
Drug: solifenacin succinate
Drug: tamsulosin
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in micturitions per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in urgency episodes per 24 hours from baseline to end of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 398
Study Start Date: May 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: solifenacin succinate
Oral
Other Names:
  • Vesicare®
  • YM905
Drug: tamsulosin
oral
Placebo Comparator: 2 Drug: tamsulosin
oral
Drug: placebo
oral

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of Overactive Bladder (OAB)

Exclusion Criteria:

  • Current use of antimuscarinic therapy
  • Evidence of a urinary tract infection
  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: NCT00333112

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35209
United States, Arizona
Phoenix, Arizona, United States, 85050
Tuscon, Arizona, United States, 85712
United States, California
Atherton, California, United States, 94027
Beverly Hills, California, United States, 90211
Buena, California, United States, 90620
Buena Park, California, United States, 90320
Carmichael, California, United States, 95608
Culver City, California, United States, 90232
Fresno, California, United States, 93720
Mission Hills, California, United States, 92084
Modesto, California, United States, 95350
Orange, California, United States, 92869
San Bernardino, California, United States, 92404
San Diego, California, United States, 92108
Torrance, California, United States, 90505
United States, Colorado
Aurora, Colorado, United States, 80012
Denver, Colorado, United States, 80210
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Danbury, Connecticut, United States, 06708
United States, Florida
Clearwater, Florida, United States, 33761
Daytona Beach, Florida, United States, 32114
Fort Myers, Florida, United States, 33908
New Port Richey, Florida, United States, 34652
Orlando, Florida, United States, 32803
Orlando, Florida, United States, 32806
Pembroke Pines, Florida, United States, 33028
Pembroke Pines, Florida, United States, 33027
Tallahassee, Florida, United States, 32308
Wellington, Florida, United States, 33414
United States, Georgia
Atlanta, Georgia, United States, 30342
Blue Ridge, Georgia, United States, 30513
Marietta, Georgia, United States, 30060
Roswell, Georgia, United States, 30076
Sandy Springs, Georgia, United States, 30328
Snellville, Georgia, United States, 30078
United States, Idaho
Coeur d'Alene, Idaho, United States, 83814
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Kansas
Wichita, Kansas, United States, 67207
United States, Louisiana
Shreveport, Louisiana, United States, 71106
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Watertown, Massachusetts, United States, 02472
United States, Michigan
Grand Rapids, Michigan, United States, 49544
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, New Jersey
West Orange, New Jersey, United States, 07052
United States, New York
Endwell, New York, United States, 13760
Garden City, New York, United States, 11530
New York, New York, United States, 10021
New York, New York, United States, 10016
Orchard Park, New York, United States, 14127
Poughkeepsie, New York, United States, 12601
Rochester, New York, United States, 14642
United States, North Carolina
Concord, North Carolina, United States, 28025
Hickory, North Carolina, United States, 28601
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45212
Cincinnati, Ohio, United States, 45249
United States, Oklahoma
Bethany, Oklahoma, United States, 73008
Norman, Oklahoma, United States, 73071
United States, Oregon
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Bala Cynwyd, Pennsylvania, United States, 19004
Bensalem, Pennsylvania, United States, 19020
Camp Hill, Pennsylvania, United States, 17011
Lancaster, Pennsylvania, United States, 17604
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77024
United States, Utah
Ogden, Utah, United States, 84403
Salt Lake City, Utah, United States, 84121
United States, Virginia
Virginia Beach, Virginia, United States, 23454
United States, Washington
Mountain Lake Terrace, Washington, United States, 98043
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Astellas US Medical Information Astellas Pharma US, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00333112     History of Changes
Other Study ID Numbers: 905-UC-008
Study First Received: June 1, 2006
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Treatment Outcome
Urology
Solifenacin succinate
Urinary Incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Solifenacin
Tamsulosin
Adrenergic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
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