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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: | March 2004 |
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: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00621647 |
Health Authority: | United States: Food and Drug Administration |
Seroquel dementia agitation symptoms |
Alzheimer's disease vascular dementia quetiapine fumarate |
Arterial Occlusive Diseases Alzheimer Disease Vascular Diseases Central Nervous System Diseases Psychomotor Agitation Arteriosclerosis 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 |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs Central Nervous System Depressants |
Cardiovascular Diseases Antipsychotic Agents Tauopathies Central Nervous System Agents Pharmacologic Actions |