NCT00308503

Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia

Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: A 6 Week, Multicenter, Randomized, Double -Blind, Placebo-controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Initiation and Maintenance Disorders
• Insomnia

Interventions

Type	Name	Description
DRUG	eplivanserin (SR46349)	oral administration
DRUG	placebo	oral administration

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2006-03-29
• Last updated: 2010-11-30

Locations

3 sites across 3 countries: United States, Australia, Canada