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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 (Alfahydro)
Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure \[LPP\] of neuropathic etiology. Secondary objectives were: * To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents, * To investigate the number of Urinary Tract Infection (UTI) episodes, * To investigate the pharmacokinetics of Alfuzosin (population kinetics).
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2007-12 |
| Completion | 2009-10 |
Conditions
- Hydronephrosis
- Neurogenic Bladder
Interventions
- Alfuzosin
Primary outcomes
- Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis — baseline and 12 weeks (efficacy study phase)
Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point. 'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for the affected kidney without worsening of the other kidney. 'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for one kidney without worsening of the other kidney.
Countries
Bulgaria, Canada, Estonia, India, Malaysia, Poland, Russia, Serbia, Singapore, Slovakia, Taiwan, Turkey (Türkiye)