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Zolpidem in adolescent insomnia
NCT00432198Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Jan 2010
- Countries
- 1
- Sponsor
- Astellas Pharma
- Drugs
- zolpidem sublingual tablet
- Conditions
- Insomnia
01
Overview
Phase 4, randomised, double-blind trial of zolpidem sublingual tablet in Insomnia (3 arms), sponsored by Astellas Pharma. Primary endpoint: Mean daily sleep latency at 2 weeks. Started Feb 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Zolpidem Arm 1
Oral Zolpidem (Myslee)
Zolpidem Arm 2
Oral Zolpidem (Myslee)
Placebo
Oral Placebo
03
Who it enrols
Adolescents (12-18 years) diagnosed with nonorganic insomnia. Excludes patients with schizophrenia, manic-depressive illness, ADHD, or insomnia caused by physical diseases.
04
Endpoints
Primary
Mean daily sleep latency
Secondary
Mean daily total hours of sleep
Mean daily frequency of intermediate awaking
Mean daily time of intermediate awaking
Impression of patient for double-blind period
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