|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00464243 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Initiation and Maintenance Disorders |
Drug: volinanserin (M100907) Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy and Safety of 2 mg/Day M100907 on Sleep Maintenance Insomnia: a 6-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Polysomnographic Study |
| Enrollment: | 604 |
| Study Start Date: | April 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: volinanserin (M100907)
oral administration
|
| 2: Placebo Comparator |
Drug: placebo
oral administration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations| United States, New Jersey | |
| Sanofi-aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Australia, New South Wales | |
| Sanofi-aventis Administrative Office | |
| Cove, New South Wales, Australia | |
| Austria | |
| Sanofi-aventis Administrative Office | |
| Vienna, Austria | |
| Canada, Quebec | |
| Sanofi-aventis Administrative Office | |
| Laval, Quebec, Canada | |
| France | |
| Sanofi-aventis Administrative Office | |
| Paris, France | |
| Germany | |
| Sanofi-aventis Administrative Office | |
| Berlin, Germany | |
| Russian Federation | |
| Sanofi-aventis Administrative Office | |
| Moscow, Russian Federation | |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | EFC6072, EUDRACT : 2006-005303-34 |
| Study First Received: | April 20, 2007 |
| Last Updated: | February 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00464243 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency |
|
Sleep problems Insomnia Sleeplessness Polysomnographic |
|
Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Mental Disorders Dyssomnias |
Sleep Disorders MDL 100907 Serotonin Sleep Disorders, Intrinsic |
|
Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Dyssomnias Sleep Disorders |
MDL 100907 Pharmacologic Actions Sleep Disorders, Intrinsic Serotonin Antagonists Serotonin Agents Mental Disorders |