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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629720
First Posted: March 6, 2008
Last Update Posted: December 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
February 26, 2008
March 6, 2008
December 15, 2009
July 2006
February 2007   (Final data collection date for primary outcome measure)
PK parameters
Same as current
Complete list of historical versions of study NCT00629720 on ClinicalTrials.gov Archive Site
Safety evaluation
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Bladder Neurogenic
Drug: alfuzosin (SL770499)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
February 2007
February 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.
Sexes Eligible for Study: All
2 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Serbia,   United States
Former Serbia and Montenegro
 
NCT00629720
PKM6270
Not Provided
Not Provided
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD Sanofi
Sanofi
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP