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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: |
NCT00300846 |
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Date of registration:
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08/03/2006 |
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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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A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
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Scientific title:
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A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia. |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00300846 |
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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 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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Austria
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Belgium
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Czech Republic
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Finland
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France
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Germany
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Hungary
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Netherlands
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Poland
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South Africa
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Spain
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Sweden
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Switzerland
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Turkey
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United Kingdom
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at
least 2.5 kg while on clozapine.
Exclusion Criteria:
- Patients known to be allergic to aripiprazole
- Hospitalized patients
- Patients who have previously received study medication in an aripiprazole clinical
study or who have participated in any clinical trial with an investigational agent
within the past month.
Age minimum:
18 Years
Age maximum:
65 Years
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: Placebo
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Drug: aripiprazole
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Primary Outcome(s)
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The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
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Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.
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Secondary Outcome(s)
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Effectiveness (IAQ, GAF)
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Patient Reported Outcomes
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Efficacy (PANSS, CGI)
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Safety
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Secondary ID(s)
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CN138-170
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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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