Status:
COMPLETED
Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties
Lead Sponsor:
Sanofi
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
- At least 1 hour of wakefulness for at least 3 nights per week during the month preceding inclusion
- Disturbances of sleep maintenance criteria based on the patient's sleep questionnaire during the run-in period
Exclusion
- Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
- Night shift workers and individuals who nap 3 or more times per week
- Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day
- Insomnia secondary to a general medical condition
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT00679900
Start Date
April 1 2008
End Date
March 1 2009
Last Update
November 30 2010
Active Locations (8)
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1
Sanofi-Aventis Administrative Office
Santiago, Chile
2
Sanofi-Aventis Administrative Office
Tallinn, Estonia
3
Sanofi-Aventis Administrative Office
Helsinki, Finland
4
Sanofi-Aventis Administrative Office
Paris, France