PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder



Status:Completed
Healthy:No
Age Range:2 - 16
Updated:4/21/2016
Start Date:April 2006
End Date:June 2009

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Trial Summary
Trial Overview
Inclusion Criteria

An Uncontrolled, Open-label, Titration, Long-term Safety (up to 12 Months) and Efficacy Study of Tamsulosin Hydrochloride in Children With Neuropathic Bladder, With a Randomized Pharmacokinetic Sub-study Investigating Low, Medium and High Dose Ranges.

Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and
evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in
children with a neuropathic bladder, over the course of 12 months of active treatment.


Inclusion Criteria:

- Neuropathic bladder secondary to known neurological disorder

- Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements
at baseline

Exclusion Criteria:

- Clinically significant abnormalities as determined by the investigator

- A history of relevant orthostatic hypotension, fainting spells or blackouts
We found this trial at
20
sites
Clinical Trial Facility in Madison Wisconsin
Madison, Wisconsin 53792
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Madison, WI
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Clinical Trial Facility in Akron Ohio
Akron, Ohio
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Akron, OH
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Clinical Trial Facility in Birmingham Alabama
Birmingham, Alabama
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Birmingham, AL
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Clinical Trial Facility in Buffalo New York
Buffalo, New York
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Buffalo, NY
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Dallas, TX
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Clinical Trial Facility in Gent
Gent,
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Gent,
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Clinical Trial Facility in Houston Texas
Houston, Texas
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Houston, TX
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Clinical Trial Facility in Indianapolis Indiana
Indianapolis, Indiana 46202
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Indianapolis, IN
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Clinical Trial Facility in Jacksonville Florida
Jacksonville, Florida 32209
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Jacksonville, FL
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Clinical Trial Facility in Lake Success New York
Lake Success, New York 11042
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Lake Success, NY
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Clinical Trial Facility in Los Angeles California
Los Angeles, California
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Los Angeles, CA
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
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Nashville, TN
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Clinical Trial Facility in Oklahoma City Oklahoma
Oklahoma City, Oklahoma
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Oklahoma City, OK
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Clinical Trial Facility in Salt Lake City Utah
Salt Lake City, Utah
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Salt Lake City, UT
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Clinical Trial Facility in Shreveport Louisiana
Shreveport, Louisiana 71103
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Shreveport, LA
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Clinical Trial Facility in Springfield Illinois
Springfield, Illinois 62704
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Springfield, IL
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Clinical Trial Facility in St Louis Missouri
St Louis, Missouri
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St Louis, MO
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Clinical Trial Facility in Tampa Florida
Tampa, Florida
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Tampa, FL
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Clinical Trial Facility in Tarrytown New York
Tarrytown, New York 10591
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from
Tarrytown, NY
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Clinical Trial Facility in Winston Salem North Carolina
Winston Salem, North Carolina 27157
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from
Winston Salem, NC
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