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

Completed · Phase 2

Conditions studied: Bladder, Neurogenic

In brief

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.

Key facts

Study ID

NCT00340704

Run by

Boehringer Ingelheim

People needed

143

Starts

2006-04-01

Expected to finish

2009-06-01

Last updated by the study team

2016-02-17

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neuropathic bladder secondary to known neurological disorder
• Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline

You may not qualify if…

• Clinically significant abnormalities as determined by the investigator
• A history of relevant orthostatic hypotension, fainting spells or blackouts

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Springfield, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — St Louis, Missouri, United States
• Study site — Buffalo, New York, United States
• Study site — Lake Success, New York, United States
• Study site — Tarrytown, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Madison, Wisconsin, United States
• Study site — Ghent, Belgium
• Study site — Santo André, Brazil
• Study site — São Paulo, Brazil
• Study site — Halifax, Canada
• Study site — Montreal, Canada
• Study site — Montreal, Canada
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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