Trials / Completed
CompletedNCT00464243
Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study
Efficacy and Safety of 2 mg/Day M100907 on Sleep Maintenance Insomnia: a 6-week, Multicenter, Randomized, Double-blind, Placebo-controlled Polysomnographic Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 604 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess efficacy and safety of volinanserin 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 non restorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | volinanserin | oral administration |
| DRUG | placebo | oral administration |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2008-01-01
- Completion
- 2008-01-01
- First posted
- 2007-04-23
- Last updated
- 2017-08-08
Locations
7 sites across 7 countries: United States, Australia, Austria, Canada, France, Germany, Russia
Source: ClinicalTrials.gov record NCT00464243. Inclusion in this directory is not an endorsement.