6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
NCT00352144 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 830
Last updated 2012-02-22
Summary
To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.
Conditions
- Primary Insomnia
Interventions
- DRUG
-
Eszopiclone
Eszopiclone 3 mg
- DRUG
-
Placebo tablet
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-31
- Primary Completion
- 2004-10-31
- Completion
- 2004-10-31
Countries
- United States
Study Locations
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