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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: |
NCT00080327 |
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Date of registration:
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26/03/2004 |
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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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Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
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Scientific title:
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A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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370 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00080327 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the
past three months
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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Schizophrenia
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Intervention(s)
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Drug: Aripiprazole
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Drug: Placebo
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Primary Outcome(s)
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Change at endpoint in schizophrenia rating scale
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Secondary Outcome(s)
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Clinical Global Improvement scale at endpoint and time to response
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Secondary ID(s)
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CN138-113 ST
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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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