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

Purpose

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	Intervention	Phase
Urinary Bladder Neurogenic	Drug: alfuzosin (SL770499)	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

PK parameters

Secondary Outcome Measures:

Safety evaluation


Enrollment:	29
Study Start Date:	July 2006
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Years to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629720

Locations


United States, Pennsylvania
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States, 19355
Serbia
Sanofi-Aventis Administrative Office
Belgrade, Serbia

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	ICD	Sanofi

More Information


Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00629720 History of Changes
Other Study ID Numbers:	PKM6270
First Submitted:	February 26, 2008
First Posted:	March 6, 2008
Last Update Posted:	December 15, 2009
Last Verified:	December 2009

Keywords provided by Sanofi:


elevated detrusor leak point pressure

Additional relevant MeSH terms:


Urinary Bladder, Neurogenic Neurologic Manifestations Nervous System Diseases Urinary Bladder Diseases Urologic Diseases Signs and Symptoms Alfuzosin Adrenergic alpha-1 Receptor Antagonists	Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents

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