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

Condition(s) targeted: Urinary Incontinence

Intervention: solifenacin succinate (Drug); tamsulosin (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Astellas US Medical Information, Study Director, Affiliation: Astellas Pharma US, Inc.

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

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in micturations per 24 hours from baseline to end of treatment

Secondary outcome: Change in urgency episodes per 24 hours from baseline to end of treatment

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

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Symptoms of Overactive Bladder (OAB)

Exclusion Criteria:

- Current use of antimuscarinic therapy

- Evidence of a urinary tract infection

Birmingham, Alabama 35209, United States

Tuscon, Arizona 85712, United States

Phoenix, Arizona 85050, United States

Modesto, California 95350, United States

San Diego, California 92108, United States

Culver City, California 90232, United States

Mission Hills, California 92084, United States

Fresno, California 93720, United States

Atherton, California 94027, United States

Buena Park, California 90320, United States

Beverly Hills, California 90211, United States

San Bernardino, California 92404, United States

Torrance, California 90505, United States

Orange, California 92869, United States

Buena, California 90620, United States

Carmichael, California 95608, United States

Aurora, Colorado 80012, United States

Wheat Ridge, Colorado 80033, United States

Denver, Colorado 80210, United States

Danbury, Connecticut 06708, United States

Tallahassee, Florida 32308, United States

Clearwater, Florida 33761, United States

Orlando, Florida 32803, United States

Pembroke Pines, Florida 33028, United States

Pembroke Pines, Florida 33027, United States

Fort Myers, Florida 33908, United States

Wellington, Florida 33414, United States

Orlando, Florida 32806, United States

Daytona Beach, Florida 32114, United States

New Port Richey, Florida 34652, United States

Roswell, Georgia 30076, United States

Snellville, Georgia 30078, United States

Marietta, Georgia 30060, United States

Blue Ridge, Georgia 30513, United States

Atlanta, Georgia 30342, United States

Sandy Springs, Georgia 30328, United States

Coeur d'Alene, Idaho 83814, United States

Evansville, Indiana 47714, United States

Wichita, Kansas 67207, United States

Shreveport, Louisiana 71106, United States

Watertown, Massachusetts 02472, United States

Boston, Massachusetts 02115, United States

Grand Rapids, Michigan 49544, United States

Jackson, Mississippi 39202, United States

West Orange, New Jersey 07052, United States

Poughkeepsie, New York 12601, United States

Garden City, New York 11530, United States

Endwell, New York 13760, United States

Rochester, New York 14642, United States

New York, New York 10021, United States

New York, New York 10016, United States

Orchard Park, New York 14127, United States

Hickory, North Carolina 28601, United States

Concord, North Carolina 28025, United States

Winston Salem, North Carolina 27103, United States

Cincinnati, Ohio 45212, United States

Cincinnati, Ohio 45249, United States

Bethany, Oklahoma 73008, United States

Norman, Oklahoma 73071, United States

Springfield, Oregon 97477, United States

Camp Hill, Pennsylvania 17011, United States

Bala Cynwyd, Pennsylvania 19004, United States

Lancaster, Pennsylvania 17604, United States

Uniontown, Pennsylvania 15401, United States

Bensalem, Pennsylvania 19020, United States

Mt. Pleasant, South Carolina 29464, United States

Simpsonville, South Carolina 29681, United States

Nashville, Tennessee 37203, United States

Houston, Texas 77024, United States

Ogden, Utah 84403, United States

Salt Lake City, Utah 84121, United States

Virginia Beach, Virginia 23454, United States

Mountain Lake Terrace, Washington 98043, United States

Spokane, Washington 99202, United States

Starting date: May 2006
Ending date: January 2007
Last updated: January 30, 2008