12-week, multicenter, double-blind, randomized, placebo-controlled, parallel-groupstudy to investigate the efficacy, pharmacodynamic and safety of two doses of alfuzosin (0.1 mg/kg/day; 0.2 mg/kg/day) in the treatment of children and adolescents 2 – 16 years of age with elevated detrusor leak point pressure of neuropathic etiology followed by a 40-week open-label extension - Alfachi

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 172

Inclusion Criteria

-Children and adolescents of either gender 2 – 16 years of age with elevated detrusor LPP of neuropathic etiology
-Detrusor leak point pressure > or = 40 cm H2O
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

-Patients who had an urological surgery in the last 4 months prior to the study
-Patients who have undergone urethral dilatation in the last 3 months prior to the baseline urodynamic assessment
-Patients who have received a-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment
-Patients who have received any detrusor injections of botulinum toxin
- Patients with urological diseases/conditions other than functional bladder obstruction of neuropathic etiology that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele)
-Patients with a history of severe respiratory, cardiovascular, gastrointestinal, metabolic, hepatic, neurologic, endocrine, or renal disease or other serious disorders, which would interfere with the interpretation of the study results
-Patients or parents/legally authorized representatives who are illiterate or are judged to be unable to understand the nature, scope and possible consequences of the study
-History of intolerance to a-blocker therapy
-History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome)
-QTcF > 450 msec at screening electrocardiogram (ECG)
-History of unexplained loss of consciousness
-Orthostatic hypotension
-Patients who have taken potent cytochrome P450-3A4 inhibitors in the last 4 weeks prior to the study
-Pregnant or breast-feeding females and females of childbearing potential not protected by effective contraceptive methods of birth control.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of alfuzosin in comparison to placebo on the detrusor leak<br>point pressure (LPP) in children and adolescents 2 – 16 years of age with elevated<br>detrusor leak point pressure of neuropathic etiology and detrusor LPP > or = 40 cm H2O;Secondary Objective: -To investigate the safety and tolerability of two doses of alfuzosin in comparison to placebo in children and adolescents<br>-To evaluate the effects of the two doses of alfuzosin in comparison to placebo on :<br>Detrusor compliance<br>Urinary tract infection<br>-To investigate the pharmacokinetics of alfuzosin (population kinetics) after 12 weeks<br>of treatment<br>-To evaluate the 12-month long-term safety of alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day;Primary end point(s): Detrusor leak point pressure (LPP) evaluated at baseline and week 12.

Secondary Outcome Measures

Name	Time	Method

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