Back to resultsPharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology (ALFACHIP)
Primary Purpose
Urinary Bladder Neurogenic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
alfuzosin (SL770499)
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Neurogenic focused on measuring elevated detrusor leak point pressure
Eligibility Criteria
Inclusion Criteria:
- Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
PK parameters
Secondary Outcome Measures
Safety evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00629720
Brief Title
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neurogenic
Keywords
elevated detrusor leak point pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alfuzosin (SL770499)
Primary Outcome Measure Information:
Title
PK parameters
Secondary Outcome Measure Information:
Title
Safety evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Malvern
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Belgrade
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
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