Official Title: “Four-Week, Open-Label, Multicenter, Randomized, Parallel-Group Study to Investigate the Pharmacokinetics, Safety, Tolerability and the Effects on Leak Point Pressure of Two Oral Doses of Alfuzosin (0.1 mg/kg/Day; 0.2 mg/kg/Day) in Children and Adolescents 2 to 16 Years-of-Age With Elevated Detrusor Leak-Point Pressure of Neuropathic Etiology”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study

Study Primary Completion Date: February 2007

Intervention(s) in this Clinical Trial

• Drug: alfuzosin

Primary Measures

• PK parameters

Secondary Measures

• Safety evaluation

Inclusion Criteria:

• Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.

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 Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00629720

Study ID Number: PKM6270

ClinicalTrials.gov Identifier: NCT00629720

Health Authority: United States: Food and Drug Administration