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NCT00629720 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 29
- Enrollment target
NCT00629720 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 29 participants.
The verdict
NCT00629720, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 29 participants
- Enrollment target
Study Summary
The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age groups (2 to 7 years and 8 to 16 years). The secondary objectives are to investigate the safety and tolerability of the 2 dose regimens and to determine the effect of the 2 dose regimens on detrusor LPP.
Interventions
- DRUG alfuzosin (SL770499)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2006-07 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00629720
The ClinicalTrials.gov registry entry for NCT00629720 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 29 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 1 intervention - of which alfuzosin (SL770499) is the first listed.
NCT00629720 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00629720 about?
NCT00629720 is a clinical study titled "Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology". The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point Pressure (LPP) (≥40 cm H2O) of neuropathic etiology stratified into 2 age gro...
What is the current status of trial NCT00629720?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 29 participants. The study started on 2006-07. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00629720?
The interventions under investigation include: alfuzosin (SL770499) (DRUG).
Who is sponsoring clinical trial NCT00629720?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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