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| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | December 19, 2007 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00154258 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
BPRS, PANSS, DIEPSS and AIMS at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Long Term Study of Clozapine in Patients With Treatment-Resistant Schizophrenia | ||||
| Official Title ICMJE | An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-Resistant Schizophrenia | ||||
| Brief Summary | Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia. |
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| Detailed Description | Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE | Drug: Clozapine | ||||
| 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 | Active, not recruiting | ||||
| Enrollment ICMJE | 19 | ||||
| Estimated Completion Date | June 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply. |
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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00154258 | ||||
| Responsible Party | External Affairs, Novartis | ||||
| Study ID Numbers ICMJE | CLEX123J1202 | ||||
| Study Sponsor ICMJE | Novartis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | December 2007 | ||||
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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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