Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
NCT ID: NCT01939184
Last Updated: 2015-06-29
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
PHASE2
796 participants
INTERVENTIONAL
2013-08-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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WC3055-01F
WC3055 12.5 mg tablet once daily for 12 weeks
WC3055
12.5, 25, 50 or 75 mg dose
WC3055-02F
WC3055 25 mg tablet once daily for 12 weeks
WC3055
12.5, 25, 50 or 75 mg dose
WC3055-03F
WC3055 50 mg tablet once daily for 12 weeks
WC3055
12.5, 25, 50 or 75 mg dose
WC3055-04F
WC3055 75 mg tablet once daily for 12 weeks
WC3055
12.5, 25, 50 or 75 mg dose
WC3055-07P
Placebo tablet once daily for 12 weeks
Placebo
Placebo
Interventions
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WC3055
12.5, 25, 50 or 75 mg dose
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening
Exclusion Criteria
45 Years
MALE
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Herman Ellman, MD
Role: STUDY_DIRECTOR
Warner Chilcott
Locations
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Warner Chilcott Investigational Study Site
Homewood, Alabama, United States
Warner Chilcott Investigational Study Site
Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Laguna Hills, California, United States
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Murrieta, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Parker, Colorado, United States
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Middlebury, Connecticut, United States
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New Britain, Connecticut, United States
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Aventura, Florida, United States
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Clearwater, Florida, United States
Warner Chilcottt Investigational Study Site
Clearwater, Florida, United States
Warner Chilcott Investigational Study Site
Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Tallahassee, Florida, United States
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Atlanta, Georgia, United States
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Sandy Springs, Georgia, United States
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Coeur d'Alene, Idaho, United States
Warner Chilcott Investigational Study Site
Chicago, Illinois, United States
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Evanston, Illinois, United States
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Melrose Park, Illinois, United States
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Springfield, Illinois, United States
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Springfield, Illinois, United States
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Anderson, Indiana, United States
Warner Chilcott Investigational Study Site
Fort Wayne, Indiana, United States
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Jeffersonville, Indiana, United States
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Muncie, Indiana, United States
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Newburgh, Indiana, United States
Warner Chilcott Investigational Study Site
West Des Moines, Iowa, United States
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Overland Park, Kansas, United States
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Shreveport, Louisiana, United States
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Elkridge, Maryland, United States
Warner Chilcott Investigational Study Site
Glen Burnie, Maryland, United States
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Owing Mills, Maryland, United States
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Towson, Maryland, United States
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Brookline, Massachusetts, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Lawrenceville, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Garden City, New York, United States
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Great Neck, New York, United States
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Kingston, New York, United States
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New York, New York, United States
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Newburgh, New York, United States
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Poughkeepsie, New York, United States
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Cary, North Carolina, United States
Warner Chilcott Investigational Study Site
Charlotte, North Carolina, United States
Warner Chilcott Investigational Study Site
Concord, North Carolina, United States
Warner Chilcott Investigational Study Site
High Point, North Carolina, United States
Warner Chilcott Investigational Study Site
Raleigh, North Carolina, United States
Warner Chilcott Investigational Study Site
Raleigh, North Carolina, United States
Warner Chilcott Investigational Study Site
Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
Warner Chilcott Investigational Study Site
Winston-Salem, North Carolina, United States
Warner Chilcott Investigational Study Site
Cincinnati, Ohio, United States
Warner Chilcott Investigational Study Site
Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
Warner Chilcott Investigational Study Site
Lyndhurst, Ohio, United States
Warner Chilcott Investigational Study Site
Bala-Cynwyd, Pennsylvania, United States
Warner Chilcott Investigational Study Site
Lancaster, Pennsylvania, United States
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Reading, Pennsylvania, United States
Warner Chilcott Investigational Study Site
Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Bristol, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Virginia Beach, Virginia, United States
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Winchester, Virginia, United States
Warner Chilcott Investigational Study Site
Mountlake Terrace, Washington, United States
Warner Chilcott Investigational Study Site
Wauwatosa, Wisconsin, United States
Countries
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Other Identifiers
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PR-05710
Identifier Type: -
Identifier Source: org_study_id
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