Status:
COMPLETED
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
20-64 years
Phase:
PHASE3
Brief Summary
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
Eligibility Criteria
Inclusion
- Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.
Exclusion
- Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00374777
Start Date
August 1 2006
End Date
June 1 2008
Last Update
August 20 2014
Active Locations (6)
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1
Chubu Region, Japan
2
Hokkaido Region, Japan
3
Kansai Region, Japan
4
Kanto Region, Japan