Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00495885 |
The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia.
The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.
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, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy and Safety of 2 mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-Study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a 12-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study |
Estimated Enrollment: | 840 |
Study Start Date: | June 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: volinanserin (M100907)
one tablet taken around bedtime
|
2: Placebo Comparator |
Drug: Placebo
one tablet taken around bedtime
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Sub-study :
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Brazil | |
Sanofi-Aventis Administrative Office | |
Sao Paulo, Brazil | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
Colombia | |
Sanofi-Aventis Administrative Office | |
Santafe de Bogota, Colombia | |
Czech Republic | |
Sanofi-Aventis Administrative Office | |
Praha, Czech Republic | |
Finland | |
Sanofi-Aventis Administrative Office | |
Helsinki, Finland | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Greece | |
Sanofi-Aventis Administrative Office | |
Athens, Greece | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milan, Italy | |
Malaysia | |
Sanofi-Aventis Administrative Office | |
Kuala Lumpur, Malaysia | |
Netherlands | |
Sanofi-Aventis Administrative Office | |
Gouda, Netherlands | |
Russian Federation | |
Sanofi-Aventis Administrative Office | |
Moscow, Russian Federation | |
South Africa | |
Sanofi-Aventis Administrative Office | |
Midrand, South Africa | |
Switzerland | |
Sanofi-Aventis Administrative Office | |
Geneva, Switzerland | |
Taiwan | |
Sanofi-Aventis Administrative Office | |
Taipei, Taiwan | |
Turkey | |
Sanofi-Aventis Administrative Office | |
Istanbul, Turkey |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | LTE6672 |
Study First Received: | July 2, 2007 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00495885 History of Changes |
Health Authority: | United States: Food and Drug Administration; South Africa: Medicines Control Council; Netherlands: Medicines Evaluation Board (MEB) |
Sleep problems insomnia sleeplessness primary insomnia insomnia disorder |
Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Metabolic Diseases Diabetes Mellitus Sleep Disorders Dyssomnias Endocrine System Diseases MDL 100907 |
Serotonin Sleep Disorders, Intrinsic Mental Disorders Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Metabolic Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Diabetes Mellitus Endocrine System Diseases Dyssomnias |
Sleep Disorders MDL 100907 Pharmacologic Actions Sleep Disorders, Intrinsic Serotonin Antagonists Serotonin Agents Mental Disorders Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |