Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology (ALFACHIP)
- Conditions
- rinary Bladder NeurogenicTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2014-004659-30-Outside-EU/EEA
- Lead Sponsor
- sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
•Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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).<br><br>;Secondary Objective: To investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.<br><br><br>;Primary end point(s): PK parameters;Timepoint(s) of evaluation of this end point: Day 1 and 7
- Secondary Outcome Measures
Name Time Method Secondary end point(s): <br>Safety evaluation<br>Change in detrusor Leak Point Pressure (DLPP);Timepoint(s) of evaluation of this end point: up to week 4<br>Baseline- week 4