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

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ClinicalTrials.gov Identifier: NCT00629720
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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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
Urinary Bladder Neurogenic Drug: alfuzosin (SL770499) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. PK parameters

Secondary Outcome Measures :
  1. Safety evaluation

Eligibility Criteria
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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
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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
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United States, Pennsylvania
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States, 19355
Serbia
Sanofi-Aventis Administrative Office
Belgrade, Serbia
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD Sanofi
More Information
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00629720     History of Changes
Other Study ID Numbers: PKM6270
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

Keywords provided by Sanofi:
elevated detrusor leak point pressure

Additional relevant MeSH terms:
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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