Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology

Urinary Bladder Neurogenic Clinical Trial

— ALFACHIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629720
• Other study ID #: PKM6270
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2008
• Last updated: December 11, 2009
• Start date: July 2006
• Est. completion date: February 2007

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder Neurogenic
• Urinary Bladder, Neurogenic

Intervention

Drug:
• alfuzosin (SL770499)

Locations

Country	Name	City	State
Serbia	Sanofi-Aventis Administrative Office	Belgrade
United States	Sanofi-Aventis Administrative Office	Malvern	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters
Secondary	Safety evaluation