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

NCT ID: NCT00333112

Last Updated: 2014-09-18

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

PHASE4

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-01-31

Brief Summary

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

Detailed Description

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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

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

solifenacin succinate

Intervention Type DRUG

Oral

tamsulosin

Intervention Type DRUG

oral

2

Group Type PLACEBO_COMPARATOR

tamsulosin

Intervention Type DRUG

oral

placebo

Intervention Type DRUG

oral

Interventions

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solifenacin succinate

Oral

Intervention Type DRUG

tamsulosin

oral

Intervention Type DRUG

placebo

oral

Intervention Type DRUG

Other Intervention Names

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Vesicare® YM905

Eligibility Criteria

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Inclusion Criteria

* Symptoms of Overactive Bladder (OAB)

Exclusion Criteria

* Current use of antimuscarinic therapy
* Evidence of a urinary tract infection
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astellas US Medical Information

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Tuscon, Arizona, United States

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Atherton, California, United States

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Beverly Hills, California, United States

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Buena, California, United States

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Buena Park, California, United States

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Carmichael, California, United States

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Culver City, California, United States

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Fresno, California, United States

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Mission Hills, California, United States

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Modesto, California, United States

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Orange, 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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Torrance, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Danbury, Connecticut, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Fort Myers, Florida, United States

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New Port Richey, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Pembroke Pines, Florida, United States

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Tallahassee, Florida, United States

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Wellington, Florida, United States

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Atlanta, Georgia, United States

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Blue Ridge, Georgia, United States

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Marietta, Georgia, United States

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Roswell, Georgia, United States

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Sandy Springs, Georgia, United States

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Snellville, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Evansville, Indiana, United States

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Wichita, Kansas, United States

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Shreveport, Louisiana, United States

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Boston, Massachusetts, United States

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Watertown, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Jackson, Mississippi, United States

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West Orange, New Jersey, United States

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Endwell, New York, United States

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Garden City, New York, United States

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New York, New York, United States

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New York, New York, United States

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Orchard Park, New York, United States

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Poughkeepsie, New York, United States

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Rochester, New York, United States

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Concord, North Carolina, United States

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Hickory, 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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Bethany, Oklahoma, United States

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Norman, Oklahoma, United States

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Springfield, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Bensalem, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Simpsonville, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Ogden, Utah, 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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Mountain Lake Terrace, Washington, United States

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Spokane, Washington, United States

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Countries

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United States

References

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Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.

Reference Type BACKGROUND
PMID: 19837435 (View on PubMed)

Other Identifiers

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905-UC-008

Identifier Type: -

Identifier Source: org_study_id

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