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NCT00253903 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,155
- Enrollment target
NCT00253903: Completed Phase 3 study, sponsored by Sanofi.
NCT00253903 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,155 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00253903, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,155 participants
- Enrollment target
Study Summary
The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
Interventions
- DRUG placebo
- DRUG eplivanserin (SR46349)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,155 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00253903 record still lists
NCT00253903 is an interventional study that assigns participants to a tested intervention. Its 1,155 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00253903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00253903 about?
NCT00253903 is a clinical study titled "Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year". The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress...
What is the current status of trial NCT00253903?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,155 participants. The study started on 2005-11. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00253903?
The interventions under investigation include: placebo (DRUG), eplivanserin (SR46349) (DRUG).
Who is sponsoring clinical trial NCT00253903?
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 NCT00253903's enrollment target sits among peer trials
1,155 238th of 2000 higher than 1,763 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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