Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359229
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2006-07-31
Brief Title:
Stilnox Treatment in Elderly Patients With Insomnia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicentre Prospective Open Label 3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP
Brief Summary:
Primary objective
1 To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China
Secondary objectives
1 To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
2 To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
1 To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China
Secondary objectives
1 To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
2 To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None