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NCT00540891 · ClinicalTrials.gov registry record · Phase 3
The Efficacy, Onset of Effect, and Safety of Alfuzosin Once Daily in the Treatment of Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Randomized, Placebo-Controlled Trial Using an Acute International Prostate Score
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 372
- Enrollment target
NCT00540891 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 372 participants.
The verdict
NCT00540891, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 372 participants
- Enrollment target
Study Summary
Primary: Evaluate the safety and onset of symptom relief using an acute I-PSS form (7 day form). Determine onset of urinary peak flow improvement after 7 days Secondary: Determine improvement in Bother Score after 7 \& 28 days; improvement in sexual function after 28 days; assess one-month efficacy and safety
Interventions
- DRUG ALFUZOSIN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2003-02 |
| Est. Completion | 2004-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00540891
The ClinicalTrials.gov registry entry for NCT00540891 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 372 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 is the first listed.
NCT00540891 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00540891 about?
NCT00540891 is a clinical study titled "The Efficacy, Onset of Effect, and Safety of Alfuzosin Once Daily in the Treatment of Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Randomized, Placebo-Controlled Trial Using an Acute International Prostate Score". Primary: Evaluate the safety and onset of symptom relief using an acute I-PSS form (7 day form). Determine onset of urinary peak flow improvement after 7 days Secondary: Determine improvement in Bother Score after 7 \& 28 days; improvement in sexual function after 28 days; assess one-month efficacy...
What is the current status of trial NCT00540891?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 372 participants. The study started on 2003-02. Estimated completion is 2004-10.
What interventions are being tested in trial NCT00540891?
The interventions under investigation include: ALFUZOSIN (DRUG).
Who is sponsoring clinical trial NCT00540891?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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