Status:
COMPLETED
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Insomnia
Eligibility:
All Genders
65-85 years
Phase:
PHASE4
Brief Summary
To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 week...
Detailed Description
A double-blind, randomized, placebo controlled, parallel group study of eszopiclone in elderly subjects with primary chronic insomnia. The study will involve up to 9 visits and subject participation w...
Eligibility Criteria
Inclusion
- Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.
Exclusion
- Subject has recent history of known clinically significant abnormal laboratory findings.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT00386334
Start Date
October 1 2006
End Date
February 1 2008
Last Update
March 14 2016
Active Locations (82)
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1
Birmingham, Alabama, United States, 35226
2
Chandler, Arizona, United States, 85225
3
Glendale, Arizona, United States, 85306
4
Tucson, Arizona, United States, 85712