Ignite Creation Date:
2024-05-05 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00629720
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2008-02-26
Brief Title:
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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 01 mgkgDay 02 mgkgDay in Children and Adolescents 2 to 16 Years-of-age With Elevated Detrusor Leak-point Pressure of Neuropathic Etiology
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALFACHIP
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None