Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
Phase 3
Completed
- Conditions
- Urinary Bladder Neurogenic
- Registration Number
- NCT00629720
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age groups (2 to 7 years and 8 to 16 years).
The secondary objectives are to investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
- Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PK parameters
- Secondary Outcome Measures
Name Time Method Safety evaluation
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇷🇸Belgrade, Serbia