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NCT00308503 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
NCT00308503 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 608 participants.
The verdict
NCT00308503, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
Study Summary
The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.
Interventions
- DRUG placebo
- DRUG eplivanserin (SR46349)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00308503
The ClinicalTrials.gov registry entry for NCT00308503 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 608 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.
NCT00308503 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00308503 about?
NCT00308503 is a clinical study titled "Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia". The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.
What is the current status of trial NCT00308503?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2006-02. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00308503?
The interventions under investigation include: placebo (DRUG), eplivanserin (SR46349) (DRUG).
Who is sponsoring clinical trial NCT00308503?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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