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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00464061 |
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, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy and Safety of 2mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-Study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a One Year, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study |
Estimated Enrollment: | 1800 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (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
|
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.
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | LTE6673, EudraCT : 2006-004942-18 |
Study First Received: | April 19, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00464061 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Italy: Ministry of Health |
Sleep problems Insomnia Sleeplessness Primary insomnia Insomnia disorder |
Sleep Initiation and Maintenance Disorders 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 |
Neurotransmitter Agents Serotonin Antagonists Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |