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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00621647 |
The purpose of this study is to determine how safe and effective Seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation symptoms in nursing home or assisted care residents.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Condition | Intervention | Phase |
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Alzheimer's Disease Vascular Dementia |
Drug: Quetiapine Fumarate Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Comparison of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Agitation Associated With Dementia. |
Enrollment: | 333 |
Study Start Date: | September 2002 |
Study Completion Date: | November 2003 |
Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
1st fixed dose
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Drug: Quetiapine Fumarate |
2: Experimental
2nd fixed dose
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Drug: Quetiapine Fumarate |
3: Sham Comparator
Placebo
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Drug: Placebo |
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca ( Hans Eriksson / Medical Science Director ) |
Study ID Numbers: | 5077US/0046, D1446L00002 |
Study First Received: | February 6, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00621647 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Seroquel dementia agitation symptoms |
Alzheimer's disease vascular dementia quetiapine fumarate |
Arterial Occlusive Diseases Tranquilizing Agents Alzheimer Disease Psychotropic Drugs Vascular Diseases Central Nervous System Depressants Central Nervous System Diseases Psychomotor Agitation Arteriosclerosis Antipsychotic Agents Brain Diseases |
Neurodegenerative Diseases Intracranial Arterial Diseases Cerebrovascular Disorders Cognition Disorders Intracranial Arteriosclerosis Quetiapine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia, Vascular Dementia Delirium |
Physiological Effects of Drugs Psychotropic Drugs Arteriosclerosis Neurodegenerative Diseases Brain Diseases Intracranial Arterial Diseases Cerebrovascular Disorders Intracranial Arteriosclerosis Mental Disorders Therapeutic Uses Dementia, Vascular Cardiovascular Diseases Dementia |
Arterial Occlusive Diseases Tranquilizing Agents Nervous System Diseases Alzheimer Disease Vascular Diseases Central Nervous System Diseases Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Quetiapine Delirium, Dementia, Amnestic, Cognitive Disorders Tauopathies Central Nervous System Agents |