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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: Completed Phase 3 study, sponsored by Sanofi.
NCT00549939 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 172 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Detrusor Leak Point Pressure (LPP) was measured by cystometry. For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained. Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment. The analysis was performed on consolidated investigators data (i.e. endo
Interventions
- DRUG Placebo
- DRUG Alfuzosin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00549939 record still lists
NCT00549939 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00549939 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00549939's enrollment target sits among peer trials
172 1448th of 2000 higher than 550 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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