Status:
COMPLETED
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
Lead Sponsor:
Sanofi
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia an...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00630175
Start Date
September 1 2003
End Date
February 1 2004
Last Update
May 18 2009
Active Locations (3)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
3
Sanofi-Aventis Administrative Office
Laval, Canada