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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: Completed Phase 3 study, sponsored by Sanofi.
NCT00308503 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 608 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00308503 record still lists
NCT00308503 is an interventional study that assigns participants to a tested intervention. The registered 608 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 (21% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00308503 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00308503's enrollment target sits among peer trials
608 603rd of 2000 higher than 1,396 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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