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

NCT00629720 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2009-12-15

No results posted yet for this study

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.

Conditions

  • Urinary Bladder Neurogenic

Interventions

DRUG

alfuzosin (SL770499)

Sponsors & Collaborators

Principal Investigators

  • ICD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States
  • Serbia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00629720 on ClinicalTrials.gov