ALFACHIP: Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00629720
Collaborator
(none)
29
2
7.1
14.5
2.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Jul 1, 2006
Actual Primary Completion Date
:
Feb 1, 2007
Actual Study Completion Date
:
Feb 1, 2007
Outcome Measures
Primary Outcome Measures
- PK parameters []
Secondary Outcome Measures
- Safety evaluation []
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Malvern | Pennsylvania | United States | 19355 |
| 2 | Sanofi-Aventis Administrative Office | Belgrade | Serbia |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: ICD, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00629720
Other Study ID Numbers:
- PKM6270
First Posted:
Mar 6, 2008
Last Update Posted:
Dec 15, 2009
Last Verified:
Dec 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: