Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413010
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2006-12-15
Brief Title:
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder GAD
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
An 8-Week Double-Blind Placebo-Controlled Phase 3 Trial of Pregabalin 150-600 mgDay in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder GAD Who Have Not Optimally Responded to Existing TherapiesGAD
Status:
COMPLETED
Status Verified Date:
2009-12
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 this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder GAD Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale HAM-A scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures
Detailed Description:
Further enrollment in this study was stopped on January 28 2008 based on the recommendation of an independent data monitoring committee The recommendation to stop the study was not based on any safety findings
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