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NCT00549939 · ClinicalTrials.gov registry record · Phase 3
Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
NCT00549939 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 172 participants.
The verdict
NCT00549939, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 172 participants
- Enrollment target
Study Summary
The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O. Secondary objectives were: * To investigate the safety and tolerability of two doses of Alfuzosin in comparison to Placebo in children and adolescents, * To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on: * Detrusor compliance, * Urinary tract infection, * To investigate the pharmacokinetics of Alfuzosin (population kinetics), * To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day. The study consisted of 2 periods: * a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then, * a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.
Interventions
- DRUG Placebo
- DRUG Alfuzosin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00549939
The ClinicalTrials.gov registry entry for NCT00549939 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00549939 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00549939 about?
NCT00549939 is a clinical study titled "Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction". The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O. Secondary objectives were: ...
What is the current status of trial NCT00549939?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2007-10. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00549939?
The interventions under investigation include: Placebo (DRUG), Alfuzosin (DRUG).
Who is sponsoring clinical trial NCT00549939?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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