Fesoterodine "add-on" Male Overactive Bladder Study

NCT ID: NCT00546637

Last Updated: 2011-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

947 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-02-28

Brief Summary

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To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.

Detailed Description

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Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fesoterodine 4mg or 8mg

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Fesoterodine 4mg or 8mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Fesoterodine

Fesoterodine 4mg or 8mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men aged 40 years and above.
* On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
* Persistent symptoms of OAB with urinary frequency \>=8 times/24 hours and micturition-related urgency episodes \>=3 episode/24 hours.

Exclusion Criteria

* Contraindication to fesoterodine (antimuscarinics).
* Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
* Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer,Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Birmingham, Alabama, United States

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Gilbert, Arizona, United States

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Gilbert, Arizona, United States

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Litchfield Park, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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La Mesa, California, United States

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Newport Beach, California, United States

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San Bernardino, 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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Aurora, Colorado, United States

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Denver, Colorado, United States

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Jupiter, Florida, United States

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Orange City, Florida, United States

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West Palm Beach, Florida, United States

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Dunwoody, Georgia, United States

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Evansville, Indiana, United States

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Jeffersonville, Indiana, United States

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Newburgh, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Baltimore, Maryland, United States

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Owings Mills, Maryland, United States

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Watertown, Massachusetts, United States

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Flint, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Troy, Michigan, United States

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Utica, Michigan, United States

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West Bloomfield, Michigan, United States

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West Bloomfield, Michigan, United States

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Minneapolis, Minnesota, United States

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Omaha, Nebraska, United States

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Sewell, New Jersey, United States

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Albany, New York, United States

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Garden City, 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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Poughkeepsie, New York, United States

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Syracuse, New York, United States

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Williamsville, New York, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Fargo, North Dakota, United States

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Fargo, North Dakota, 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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Bethany, Oklahoma, United States

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Portland, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Antwerp, , Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Salvador, Estado de Bahia, Brazil

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Curitiba, Paraná, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campos do Jordão, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Barrie, Ontario, Canada

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North Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Medellín, Antioquia, Colombia

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Bogota, Cundinamarca, Colombia

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Berlin, , Germany

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Frankfurt, , Germany

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Göttingen, , Germany

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Hagenow, , Germany

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Lauenburg, , Germany

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Leipzig, , Germany

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Oberursel, , Germany

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Wiesbaden, , Germany

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Ioannina, Ipiros, Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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New Delhi, New Delhi, India

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Ludhiana, Punjab, India

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Lucknow, Uttar Pradesh, India

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Lucknow, Uttar Pradesh, India

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Kuching, Sarawak, Malaysia

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Kuching, Sarawak, Malaysia

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Roermond, , Netherlands

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Tilburg, , Netherlands

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Zutphen, , Netherlands

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Bodø, , Norway

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Oslo, , Norway

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Cebu City, Cebu, Philippines

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Quezon City, Philippines, Philippines

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Bacolod City, , Philippines

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Makati City, , Philippines

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Manila, , Philippines

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Manila, , Philippines

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Bialystok, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Lodz, , Poland

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Mysłowice, , Poland

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Wroclaw, , Poland

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Singapore, Singapore, Singapore

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Singapore, Singapore, Singapore

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Bratislava, Slovakia, Slovakia

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Martin, Slovakia, Slovakia

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Piešťany, Slovakia, Slovakia

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Banská Bystrica, , Slovakia

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Skalica, , Slovakia

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Bucheon-si, Gyunggi-do, South Korea

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Pusan, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Martorell, Barcelona, Spain

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Getafe, Madrid, Spain

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Manacor, Palma de Mallorca, Spain

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Borås, , Sweden

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Jönköping, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Ratchathewi, Bangkok, Thailand

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Amphoe Mueang, Chiang Mai, Thailand

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Countries

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United States Belgium Brazil Canada Colombia Germany Greece India Malaysia Netherlands Norway Philippines Poland Singapore Slovakia South Korea Spain Sweden Thailand

Related Links

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Other Identifiers

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A0221009

Identifier Type: -

Identifier Source: org_study_id

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