Phase 3 /Seroquel SR Acute Mania Monotherapy - US
Study identifier:D144CC00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Affective Psychosis, Bipolar
Phase
Phase 3
Healthy volunteers
No
Study drug
Quetiapine fumarate (Seroquel) SR
Sex
All
Actual Enrollment
447
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Jan 2007
Primary Completion Date: -
Study Completion Date: 01 Jul 2007
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 |
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Contacts
Investigators
Principal Investigator
Catherine Datto
AstraZeneca
