Official Title: “12-Week, Multicenter, Open-Label, Non-Comparative Study to Investigate Pharmacodynamic and Safety of Alfuzosin 0.2 mg/kg/Day in the Treatment of Children and Adolescents 2 - 16 Years of Age With Hydronephrosis Associated With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-Week Open-Label Extension”

To evaluate the efficacy of alfuzosin in children with progressive hydronephrosis due to elevated detrusor leak point pressure of neuropathic etiology

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: alfuzosin (SL770499)
  • oral solution or tablets depending on the age group

Primary Measures

• Change in grade of hydronephrosis
  • Time Frame: at week 12 (end of efficacy study phase)
    Safety Issue?: No

Secondary Measures

• Number of documented urinary tract infections
  • Time Frame: after 12 weeks and 52 weeks (end of safety extension phase)
    Safety Issue?: No
• Pharmacokinetics of alfuzosin
  • Time Frame: 52 weeks
    Safety Issue?: No
• Safety of alfuzosin
  • Time Frame: 52 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Patients with elevated detrusor Leak Point Pressure of neuropathic etiology and with hydronephrosis grade 1, 2 or 3

Exclusion Criteria:

• Hydronephrosis of non-neuropathic etiology
• 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 alpha-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment
• Patients who have received any detrusor injections of botulinum toxin in the last 6 months
• 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)
• History of intolerance to alpha-blocker therapy
• Orthostatic hypotension
• History of risk factors for Torsade de pointes (e.g., family history of Long QT
• Syndrome)
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576823

Study ID Number: EFC6269

ClinicalTrials.gov Identifier: NCT00576823

Health Authority: United States: Food and Drug Administration