Ignite Creation Date:
2024-05-05 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00576823
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2007-12-18
Brief Title:
Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
12-week Multicenter Open-label Non-comparative Study to Investigate Pharmacodynamic and Safety of Alfuzosin 02 mgkgDay in the Treatment of Children and Adolescents 2 - 16 Years of Age With Hydronephrosis Associated With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension
Status:
COMPLETED
Status Verified Date:
2014-10
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:
Alfahydro
Brief Summary:
Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure LPP of neuropathic etiology
Secondary objectives were
To investigate the safety and tolerability of alfuzosin 02 mgkgday in children and adolescents
To investigate the number of Urinary Tract Infection UTI episodes
To investigate the pharmacokinetics of Alfuzosin population kinetics
Secondary objectives were
To investigate the safety and tolerability of alfuzosin 02 mgkgday in children and adolescents
To investigate the number of Urinary Tract Infection UTI episodes
To investigate the pharmacokinetics of Alfuzosin population kinetics
Detailed Description:
The study consisted of 2 phases
a 12-week efficacy phase then
a 40-week safety extension phase
All eligible subjects received alfuzosin 02 mgkgday The formulation and the frequency was assigned by Interactive Voice Response System IVRS according to age group and ability to swallow tablets
Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study The treatment was the same as in the 12-week efficacy phase
All patients had a one-week follow-up period after the last dose intake
a 12-week efficacy phase then
a 40-week safety extension phase
All eligible subjects received alfuzosin 02 mgkgday The formulation and the frequency was assigned by Interactive Voice Response System IVRS according to age group and ability to swallow tablets
Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study The treatment was the same as in the 12-week efficacy phase
All patients had a one-week follow-up period after the last dose intake
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-002397-38 | EUDRACT_NUMBER | None | None |
| SL770499 | None | None | None |