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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

796 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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WC3055-01F

WC3055 12.5 mg tablet once daily for 12 weeks

Group Type EXPERIMENTAL

WC3055

Intervention Type DRUG

12.5, 25, 50 or 75 mg dose

WC3055-02F

WC3055 25 mg tablet once daily for 12 weeks

Group Type EXPERIMENTAL

WC3055

Intervention Type DRUG

12.5, 25, 50 or 75 mg dose

WC3055-03F

WC3055 50 mg tablet once daily for 12 weeks

Group Type EXPERIMENTAL

WC3055

Intervention Type DRUG

12.5, 25, 50 or 75 mg dose

WC3055-04F

WC3055 75 mg tablet once daily for 12 weeks

Group Type EXPERIMENTAL

WC3055

Intervention Type DRUG

12.5, 25, 50 or 75 mg dose

WC3055-07P

Placebo tablet once daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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WC3055

12.5, 25, 50 or 75 mg dose

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* History of LUTS for ≥6 months secondary to BPH
* Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening

Exclusion Criteria

\-
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Huntsville, Alabama, United States

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Warner Chilcott Investigational Study Site

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

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Warner Chilcottt Investigational Study Site

Clearwater, Florida, United States

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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

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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

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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

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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

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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

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Charlotte, North Carolina, United States

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Concord, North Carolina, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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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

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Lyndhurst, Ohio, United States

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Bala-Cynwyd, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Reading, Pennsylvania, United States

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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

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Mountlake Terrace, Washington, United States

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Wauwatosa, Wisconsin, United States

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Countries

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United States

Other Identifiers

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PR-05710

Identifier Type: -

Identifier Source: org_study_id

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