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Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology (Alfahydro)
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00576823
  Purpose

To evaluate the efficacy of alfuzosin in children with progressive hydronephrosis due to elevated detrusor leak point pressure of neuropathic etiology


Condition Intervention Phase
Hydronephrosis
Neurogenic Bladder
Drug: alfuzosin (SL770499)
Phase III

Drug Information available for: Alfuzosin Alfuzosin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: 12-Week, Multicenter, Open-Label, Non-Comparative Study to Investigate Pharmacodynamic and Safety of Alfuzosin 0.2 mg/kg/Day 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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Change in grade of hydronephrosis [ Time Frame: at week 12 (end of efficacy study phase) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of documented urinary tract infections [ Time Frame: after 12 weeks and 52 weeks (end of safety extension phase) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of alfuzosin [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Safety of alfuzosin [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: alfuzosin (SL770499)
    oral solution or tablets depending on the age group
  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with elevated detrusor Leak Point Pressure of neuropathic etiology and with hydronephrosis grade 1, 2 or 3

Exclusion Criteria:

  • Hydronephrosis of non-neuropathic etiology
  • Patients who had an urological surgery in the last 4 months prior to the study
  • Patients who have undergone urethral dilatation in the last 3 months prior to the baseline urodynamic assessment
  • Patients who have received alpha-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment
  • Patients who have received any detrusor injections of botulinum toxin in the last 6 months
  • Patients with urological diseases/conditions other than functional bladder obstruction of neuropathic etiology that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele)
  • History of intolerance to alpha-blocker therapy
  • Orthostatic hypotension
  • History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576823

Locations
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Estonia
Sanofi-Aventis Administrative Office
Tallin, Estonia
India
Sanofi-Aventis Administrative Office
Mumbai, India
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Serbia
Sanofi-Aventis Administrative Office
Belgrade, Serbia
Singapore
Sanofi-Aventis Aministrative Office
Singapore, Singapore
Slovakia
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: ICD CSD Sanofi-Aventis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC6269, SL770499, EudraCT 2004-002397-38
Study First Received: December 18, 2007
Last Updated: November 14, 2008
ClinicalTrials.gov Identifier: NCT00576823  
Health Authority: United States: Food and Drug Administration;   Poland: Ministry of Health;   Serbia: Ethics Committee

Keywords provided by Sanofi-Aventis:
child
bladder
neuropathic
alpha blockers

Study placed in the following topic categories:
Urinary Bladder, Neurogenic
Signs and Symptoms
Hydronephrosis
Alfuzosin
Cystocele
Urologic Diseases
Urinary Bladder Diseases
Neurologic Manifestations
Kidney Diseases

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009