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NCT00253968 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 967
- Enrollment target
NCT00253968: Completed Phase 3 study, sponsored by Sanofi.
NCT00253968 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 967 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00253968, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 967 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 967 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00253968 record still lists
NCT00253968 is an interventional study that assigns participants to a tested intervention. The registered 967 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00253968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00253968 about?
NCT00253968 is a clinical study titled "Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia". 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 NCT00253968?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 967 participants. The study started on 2005-11. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00253968?
The interventions under investigation include: placebo (DRUG), Eplivanserin (DRUG).
Who is sponsoring clinical trial NCT00253968?
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 NCT00253968's enrollment target sits among peer trials
967 330th of 2000 higher than 1,671 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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