drugset / Trial / NCT00253903

Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year

NCT00253903

Phase 3 Completed 1155 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-11
Primary completion
2007-11
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject eplivanserin Small molecule 5 mg Oral