Study identifier:D1444C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients with Acute Episode
schizophrenia
Phase 3
No
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR), Chlorpromazine
All
388
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.
Location
Location
Shanghai, China
Location
Ha Er Bin, Heilongjiang, China
Location
Wuhan, Hubei, China
Location
Nanjing, Jiangsu, China
Location
Beijing, China
Location
Guangzhou, Guangdong, China
Location
Kunming, Yunnan, China
Location
Baoding, Hebei, China
Arms | Assigned Interventions |
---|---|
Experimental: 1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day) | Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) 200 mg or 300 mg, oral, single dose Other Name: Seroquel_XR (Quetiapine Fumarate XR) |
Active Comparator: 2-Chlorpromazine Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days) | Drug: Chlorpromazine 50 mg, oral, double dose |
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