Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106860
Status:
COMPLETED
Last Update Posted:
2008-01-09
First Post:
2005-03-31
Brief Title:
A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
A Long-Term Open Label Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder GAD
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to assess the safety and effectiveness of the experimental drug a benzodiazepine drug in long-term use and the effects on quality of life social and occupational functioning sleep and daytime sedation in subjects with anxiety disorder
Detailed Description:
This trial is a long-term open label safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder GAD To enroll in this study investigators and patients must have first participated in Jazz Pharmaceuticals Inc Protocol 04-001-01 The study is designed for four stages that should last a total of 37 weeks
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