Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
NCT00432198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2017-02-17
Summary
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
Conditions
Interventions
- DRUG
-
Zolpidem (Myslee®)
Oral
- DRUG
-
Oral
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Use Central Contact · Astellas Pharma Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-02-28
- Primary Completion
- 2010-01-31
- Completion
- 2010-01-31
Countries
- Japan
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