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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,155 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00253903
The ClinicalTrials.gov registry entry for NCT00253903 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,155 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.
NCT00253903 reports 0 study locations.
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.
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