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
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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 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 |

- PK parameters
- Safety evaluation

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Ages Eligible for Study: | 2 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children and adolescents of either gender 2-16 years of age with elevated detrusor LPP of neuropathic etiology.

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
United States, Pennsylvania | |
Sanofi-Aventis Administrative Office | |
Malvern, Pennsylvania, United States, 19355 | |
Serbia | |
Sanofi-Aventis Administrative Office | |
Belgrade, Serbia |
Study Director: | ICD | Sanofi |
Responsible Party: | ICD Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00629720 |
Other Study ID Numbers: |
PKM6270 |
First Posted: | March 6, 2008 Key Record Dates |
Last Update Posted: | December 15, 2009 |
Last Verified: | December 2009 |
elevated detrusor leak point pressure |
Urinary Bladder, Neurogenic Neurologic Manifestations Nervous System Diseases Urinary Bladder Diseases Urologic Diseases 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 |