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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00576823 |
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 |
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 |
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) |
Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
Study Director: | ICD CSD | Sanofi-Aventis |
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 |
child bladder neuropathic alpha blockers |
Urinary Bladder, Neurogenic Signs and Symptoms Hydronephrosis Alfuzosin Cystocele |
Urologic Diseases Urinary Bladder Diseases Neurologic Manifestations Kidney Diseases |
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 |