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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00640601 |
A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects with Schizophrenia.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Quetiapine Fumarate Extended- Release |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Multicentre, Open-Label, Prospective Long-Term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects With Schizophrenia |
Estimated Enrollment: | 500 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: Subjects on a b.i.d regimen of seroquel IR for 7 days prior to enrolment are eligible to participate in the study.
Exclusion Criteria:
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
Contact: Canada Clinical Study Information | (905) 804-5841 | duncan.jewell@astrazeneca.com |
Principal Investigator: | Pierre Chue, MD | University of Alberta |
Study Chair: | Svante Nyberg, MD | AstraZeneca R&DSodertalje, Sweden |
Responsible Party: | AstraZeneca ( Hans Eriksson - Medical Science Director ) |
Study ID Numbers: | D1443L00025 |
Study First Received: | March 17, 2008 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00640601 History of Changes |
Health Authority: | Canada: Health Canada |
Seroquel schizophrenia Extended Release |
Schizophrenia Quetiapine Tranquilizing Agents Mental Disorders Psychotropic Drugs |
Central Nervous System Depressants Psychotic Disorders Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Quetiapine Tranquilizing Agents Mental Disorders Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |