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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00510211 |
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Date of registration:
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30/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.
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Scientific title:
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An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients. |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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1131 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00510211 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Germany
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Greece
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-615-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients suffering from schizophrenic or schizoaffective disorders based on the
disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45
preceding days.
- patients suffering from bipolar disorders based on the disease diagnostic criteria
DSM IV and being prescribed olanzapine during the 45 preceding days for one of the
following:
- moderate or severe manic episode
- relapse prevention in patients with bipolar disorder
Exclusion Criteria:
- current treatment with any investigational drug or procedure at entry or during the
whole study
- hypersensitivity to olanzapine
- patients with known narrow angle glaucoma risk
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder
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Schizophrenia
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Intervention(s)
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Drug: olanzapine
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Secondary ID(s)
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11610
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F1D-FR-B035
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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