Official Title: “12-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy, Pharmacodynamic and Safety of 2 Doses of Alfuzosin in the Treatment of Children and Adolescents 2-16 Years With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-Week Open-Label Extension”

The primary objective of the study is to evaluate the efficacy of alfuzosin in comparison to placebo on the detrusor leak point pressure (LPP) in children with elevated detrusor leak point pressure of neuropathic etiology and detrusor LPP≥ 40 cm H2O.

Secondary objectives are to investigate the safety and the pharmacokinetics of two doses of alfuzosin in children and adolescents. The 12 week double blind study phase is followed by a 40-week open label extension with alfuzosin (patients on placebo in the double-blind phase are switched to alfuzosin).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel 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
• Drug: Placebo
  • oral solution or tablets depending on the age group

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • dose level 1
• Experimental: 2
  • dose level 2
• Placebo Comparator: 3

Primary Measures

• Detrusor leak point pressure (LPP)
  • Time Frame: after 12 weeks
    Safety Issue?: No

Secondary Measures

• Relative change in detrusor LPP and relative change in detrusor compliance
  • Time Frame: after 12 weeks
    Safety Issue?: No
• Number of documented urinary tract infections
  • Time Frame: 12 weeks
    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 LPP of neuropathic etiology

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 α-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 α-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/NCT00549939

Study ID Number: EFC5722

ClinicalTrials.gov Identifier: NCT00549939

Health Authority: United States: Food and Drug Administration