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An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms

NCT ID: NCT01726270

Last Updated: 2020-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

689 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-03-31

Brief Summary

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Multicenter trial conducted in Pharmacy retail centers

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Lower Urinary Tract Symptoms Overactive Bladder Benign Prostatic Hyperplasia (BPH)
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Detailed Description

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Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tamsulosin hydrochloride

patients will take drug for 8 weeks in this exploratory study

Group Type EXPERIMENTAL

tamsulosin

Intervention Type DRUG

0.4 mg

Interventions

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tamsulosin

0.4 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Men 18 years of age and older.
2. Able to speak, read and understand English.
3. Willing to participate in the study and voluntarily sign an informed consent document.

Exclusion Criteria

1\. Subject or anyone in their household is currently employed by a marketing or marketing research company, and advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company as a healthcare professional or healthcare practice.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Hoover, Alabama, United States

Site Status

Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Site Status

Boehringer Ingelheim Investigational Site

Encino, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Garden Grove, California, United States

Site Status

Boehringer Ingelheim Investigational Site

La Habra, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Anoka, Minnesota, United States

Site Status

Boehringer Ingelheim Investigational Site

Elk River, Minnesota, United States

Site Status

Boehringer Ingelheim Investigational Site

Fridley, Minnesota, United States

Site Status

Boehringer Ingelheim Investigational Site

Roseville, Minnesota, United States

Site Status

Boehringer Ingelheim Investigational Site

Saint Francis, Minnesota, United States

Site Status

Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

Boehringer Ingelheim Investigational Site

Longview, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Tyler, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Bountiful, Utah, United States

Site Status

Boehringer Ingelheim Investigational Site

Layton, Utah, United States

Site Status

Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

Boehringer Ingelheim Investigational Site

Syracuse, Utah, United States

Site Status

Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Roehrborn CG, Lowe FC, Gittelman M, Wruck JM, Verbeek AE. Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin. Drugs Aging. 2019 Feb;36(2):179-188. doi: 10.1007/s40266-018-0621-8.

Reference Type DERIVED
PMID: 30607798 (View on PubMed)

Other Identifiers

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527.82

Identifier Type: -

Identifier Source: org_study_id

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