Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314210
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2006-04-11
Brief Title:
Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multi-CentreDouble-BlindRandomised-WithdrawalParallel-Group Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period
Status:
COMPLETED
Status Verified Date:
2009-03
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:
PLATINUM
Brief Summary:
The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder GAD
PLEASE NOTE Seroquel SR and Seroquel XR refer to the same formulation The SR designation was changed to XR after consultation with FDA
PLEASE NOTE Seroquel SR and Seroquel XR refer to the same formulation The SR designation was changed to XR after consultation with FDA
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT Number 2005-005055-18 | None | None | None |