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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00679900 |
The primary objective is to compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.
The secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.
Condition | Intervention | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders |
Drug: eplivanserin (SR46349) Drug: lormetazepam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of the Safety and Efficacy of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week, Randomized, Double-Blind,Comparative, Parallel-Group Study |
Estimated Enrollment: | 266 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: eplivanserin (SR46349)
5 mg/day
|
2: Active Comparator |
Drug: lormetazepam
1 mg/day
|
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.
Contact: Public Registry ICD | GV-Contact-us@sanofi-aventis.com |
Chile | |
Sanofi-Aventis Administrative Office | Recruiting |
Santiago, Chile | |
Contact GV-Contact-us@sanofi-aventis.com | |
Estonia | |
Sanofi-Aventis Administrative Office | Recruiting |
Tallinn, Estonia | |
Contact GV-Contact-us@sanofi-aventis.com | |
Finland | |
Sanofi-Aventis Administrative Office | Recruiting |
Helsinki, Finland | |
Contact GV-Contact-us@sanofi-aventis.com | |
France | |
Sanofi-Aventis Administrative Office | Recruiting |
Paris, France | |
Contact GV-Contact-us@sanofi-aventis.com | |
Netherlands | |
Sanofi-Aventis Administrative Office | Recruiting |
Gouda, Netherlands | |
Contact GV-Contact-us@sanofi-aventis.com | |
Norway | |
Sanofi-Aventis Administrative Office | Recruiting |
Lysaker, Norway | |
Contact GV-Contact-us@sanofi-aventis.com | |
Portugal | |
Sanofi-Aventis Administrative Office | Recruiting |
Porto Salvo, Portugal | |
Contact GV-Contact-us@sanofi-aventis.com | |
Spain | |
Sanofi-Aventis Administrative Office | Recruiting |
Barcelona, Spain | |
Contact GV-Contact-us@sanofi-aventis.com | |
Turkey | |
Sanofi-Aventis Administrative Office | Recruiting |
Istanbul, Turkey | |
Contact GV-Contact-us@sanofi-aventis.com |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD study director ) |
Study ID Numbers: | EFC10480, EudraCT 2007-003822-28 |
Study First Received: | May 7, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00679900 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Primary Insomnia Sleep Maintenance Difficulties |
Sleep Initiation and Maintenance Disorders Mental Disorders SR 46349B Dyssomnias |
Sleep Disorders Serotonin Lormetazepam Sleep Disorders, Intrinsic |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Hematologic Agents Central Nervous System Depressants Fibrinolytic Agents Cardiovascular Agents |
Pharmacologic Actions Serotonin Antagonists Fibrin Modulating Agents Serotonin Agents Therapeutic Uses Hypnotics and Sedatives Platelet Aggregation Inhibitors Central Nervous System Agents |