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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 26, 2004 |
| Last Updated Date | August 21, 2008 |
| Start Date ICMJE | November 2003 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
Change at endpoint in schizophrenia rating scale |
| Original Primary Outcome Measures ICMJE |
change at endpoint in schizophrania rating scale |
| Change History | Complete list of historical versions of study NCT00080327 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Clinical Global Improvement scale at endpoint and time to response |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia |
| Official Title ICMJE | A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia |
| Brief Summary | A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia |
| Detailed Description | |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE | Schizophrenia |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 370 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00080327 |
| Responsible Party | |
| Study ID Numbers ICMJE | CN138-113 ST |
| Study Sponsor ICMJE | Bristol-Myers Squibb |
| Collaborators ICMJE | Otsuka America Pharmaceutical |
| Investigators ICMJE | |
| Information Provided By | Bristol-Myers Squibb |
| Verification Date | August 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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