Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422123
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2007-01-12
Brief Title:
Phase 3 Seroquel SR Acute Mania Monotherapy - US
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Parallel-Group Placebo Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate SEROQUEL Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
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:
None
Brief Summary:
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate Seroquel in the treatment of patients with Acute Bipolar Mania for 3 weeks
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