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CompletedNCT00653562

Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography

Single Blind, Multi-center, Post Marketing Clinical Study of Zolpidem (Myslee) in Adolescent Patients With Insomnia - Evaluation With Polysomnography

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Astellas Pharma Inc · Industry
Sex
All
Age
12 Years – 18 Years
Healthy volunteers
Not accepted

Summary

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

Detailed description

The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .

Conditions

Interventions

TypeNameDescription
DRUGzolpidemOral

Timeline

Start date
2006-11-01
Primary completion
2010-03-01
Completion
2010-03-01
First posted
2008-04-07
Last updated
2017-02-17

Locations

4 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT00653562. Inclusion in this directory is not an endorsement.

Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography (NCT00653562) · Clinical Trials Directory