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A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

NCT ID: NCT00793819

Last Updated: 2012-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

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Detailed Description

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This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Conditions

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Nocturia 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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1 Silodosin

Group Type EXPERIMENTAL

silodosin

Intervention Type DRUG

α1-adrenergic antagonist

2 Placebo

Group Type PLACEBO_COMPARATOR

silodosin

Intervention Type DRUG

α1-adrenergic antagonist

Interventions

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silodosin

α1-adrenergic antagonist

Intervention Type DRUG

Other Intervention Names

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Rapaflo

Eligibility Criteria

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Inclusion Criteria

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH and nocturia (\>=2 episodes per night)

Exclusion Criteria

* Medical conditions that would confound the efficacy evaluation.
* Medical conditions in which it would be unsafe to use an alpha-blocker.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with this alpha-blocker.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim Caramelli, MS

Role: STUDY_DIRECTOR

Watson Pharmaceuticals

Locations

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Watson Investigational Site

Huntsville, Alabama, United States

Site Status

Watson Investigational Site

Laguna Hills, California, United States

Site Status

Watson Investigational Site

San Diego, California, United States

Site Status

Watson Investigational Site

Aventura, Florida, United States

Site Status

Watson Investigational Site

Clearwater, Florida, United States

Site Status

Watson Investigational Site

Orlando, Florida, United States

Site Status

Watson Investigational Site

Marietta, Georgia, United States

Site Status

Watson Investigational Site

Sandy Springs, Georgia, United States

Site Status

Watson Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

Watson Investigational Site

West Des Moines, Iowa, United States

Site Status

Watson Investigational Site

Paducah, Kentucky, United States

Site Status

Watson Investigational Site

Greenbelt, Maryland, United States

Site Status

Watson Investigational Site

Troy, Michigan, United States

Site Status

Watson Investigational Site

Missoula, Montana, United States

Site Status

Watson Investigational Site

Omaha, Nebraska, United States

Site Status

Watson Investigational Site

Las Vegas, Nevada, United States

Site Status

Watson Investigational Site

Lawrenceville, New Jersey, United States

Site Status

Watson Investigational Site

Albuquerque, New Mexico, United States

Site Status

Watson Investigational Site

Bay Shore, New York, United States

Site Status

Watson Investigational Site

New York, New York, United States

Site Status

Watson Investigational Site

Williamsville, New York, United States

Site Status

Watson Investigational Site

Concord, North Carolina, United States

Site Status

Watson Investigational Site

Salisbury, North Carolina, United States

Site Status

Watson Investigational Site

Bethany, Oklahoma, United States

Site Status

Watson Investigational Site

Bala-Cynwyd, Pennsylvania, United States

Site Status

Watson Investigational Site

Myrtle Beach, South Carolina, United States

Site Status

Watson Investigational Site

Burien, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SI08005

Identifier Type: -

Identifier Source: org_study_id

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