Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425243
Status:
COMPLETED
Last Update Posted:
2009-04-06
First Post:
2007-01-19
Brief Title:
Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia ZOLONG
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 125 mg Compared to Placebo When Both Are Administered Over a Long-Term Period as Needed in Patients With Chronic Primary Insomnia
Status:
COMPLETED
Status Verified Date:
2009-04
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:
None
Brief Summary:
The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 125 mg in comparison with placebo when administered over a long-term period on an as needed basis in patients with chronic primary insomnia
Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 125 mg in comparison to placebo administered over a long-term period on an as needed basis
Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 125 mg in comparison to placebo administered over a long-term period on an as needed basis
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