Status:
COMPLETED
A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Sleep Initiation and Maintenance Disorders
Sleep Disorders
Eligibility:
All Genders
20-64 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Mysle...
Eligibility Criteria
Inclusion
- Clinical diagnosis of nonorganic insomnia.
- Must be able to swallow tablets
Exclusion
- Allergic reactions to zolpidem (Myslee)
- Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
876 Patients enrolled
Trial Details
Trial ID
NCT00283946
Start Date
February 1 2006
End Date
November 1 2007
Last Update
August 20 2014
Active Locations (8)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kansai Region, Japan