PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
NCT00340704 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143
Last updated 2016-02-17
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 neuropathic bladder, over the course of 12 months of active treatment.
Conditions
- Bladder, Neurogenic
Interventions
- DRUG
-
tamsulosin hydrochloride
oral
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2009-06-30
- Completion
- 2009-06-30
Countries
- United States
- Belgium
- Brazil
- Canada
- Germany
- India
- Italy
- Mexico
- Philippines
- Russia
- South Africa
- South Korea
- Spain
- Ukraine
Study Locations
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