Efficacy and Safety Study of Seroquel SR in the treatment of Generalised Anxiety Disorder
Study identifier:D1448C00015
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients with Generalised Anxiety Disorder
Medical condition
Anxiety Disorders
Phase
Phase 3
Healthy volunteers
No
Study drug
Quetiapine XR, Placebo
Sex
All
Actual Enrollment
450
Study type
Interventional
Age
66 Years +
Date
Study Start Date: 01 Sept 2006
Primary Completion Date: 01 Apr 2008
Study Completion Date: 01 Apr 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Quetapine XR Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily. | Drug: Quetiapine XR Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period. |
| Placebo Comparator: Placebo Matching placebo tablets orally administered once daily. | Drug: Placebo Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period. |
Contacts
Investigators
Principal Investigator
Ricardo Ruiz
AstraZeneca
