Status:
COMPLETED
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Bladder, Neurogenic
Eligibility:
All Genders
2-16 years
Phase:
PHASE2
Brief Summary
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 neurop...
Eligibility Criteria
Inclusion
- Neuropathic bladder secondary to known neurological disorder
- Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline
Exclusion
- Clinically significant abnormalities as determined by the investigator
- A history of relevant orthostatic hypotension, fainting spells or blackouts
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00340704
Start Date
April 1 2006
End Date
June 1 2009
Last Update
February 17 2016
Active Locations (72)
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1
Birmingham, Alabama, United States, 35233
2
Los Angeles, California, United States, 90027
3
Jacksonville, Florida, United States, 32207
4
Tampa, Florida, United States, 33614