Clinical trial
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia…
NCT00253903 · Sanofi, Industry · Completed
Key facts
| NCT number | NCT00253903 |
|---|---|
| Title | Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year |
| Official title | Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open Treatment Phase Extension With Eplivanserin for a 40-week Period |
| Acronym | EPLILONG |
| Lead sponsor | Sanofi, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Sleep Initiation and Maintenance Disorders, Insomnia |
| Intervention type | Drug |
| Interventions | eplivanserin (SR46349), placebo |
| Enrollment | 1,155 |
| Start date | Nov 1, 2005 |
| Primary completion | Nov 1, 2007 |
| Completion | Sep 1, 2008 |
| First posted | Nov 15, 2005 |
| Last update posted | Nov 30, 2010 |
| Countries | Argentina, Australia, Austria, Canada, Chile, Czechia, Finland, France, Germany, Mexico, Netherlands, Spain and 2 more |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: