Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
NCT ID: NCT00432198
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
122 participants
INTERVENTIONAL
2007-02-28
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Oral
Zolpidem (Myslee®)
Oral
2
Oral
Zolpidem (Myslee®)
Oral
3
Oral
placebo
Oral
Interventions
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Zolpidem (Myslee®)
Oral
placebo
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients whose age at the time of obtaining consent is 12 years or over and 18 years or below
Exclusion Criteria
* patients with insomnia caused by physical diseases
* patients having a history of hypersensitivity to zolpidem
* patients with attention-deficit hyperactivity disorder
12 Years
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Chubu Region, , Japan
Chugoku Region, , Japan
Hokkaido Region, , Japan
Kansai Region, , Japan
Kanto Region, , Japan
Kyushyu Region, , Japan
Shikoku Region, , Japan
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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6199-JC-0001
Identifier Type: -
Identifier Source: org_study_id
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