Health Evaluation of Abilify Long-term Therapy (HEALTH)
This study has been completed.
Sponsor:
Taiwan Otsuka Pharm. Co., Ltd
Information provided by:
Taiwan Otsuka Pharm. Co., Ltd
ClinicalTrials.gov Identifier:
NCT00520650
First received: August 23, 2007
Last updated: December 15, 2009
Last verified: December 2009
| Tracking Information | |||||
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| First Received Date ICMJE | August 23, 2007 | ||||
| Last Updated Date | December 15, 2009 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment. [ Time Frame: Throughout the study ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00520650 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Health Evaluation of Abilify Long-term Therapy | ||||
| Official Title ICMJE | Health Evaluation of Abilify Long-term Therapy | ||||
| Brief Summary | This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated. |
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| Detailed Description | Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Aripiprazole | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 245 | ||||
| Completion Date | April 2009 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00520650 | ||||
| Other Study ID Numbers ICMJE | 31-06-P01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Edward C.Y. Peng, Taiwan Otsuka Pharm. Co., Ltd | ||||
| Study Sponsor ICMJE | Taiwan Otsuka Pharm. Co., Ltd | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Taiwan Otsuka Pharm. Co., Ltd | ||||
| Verification Date | December 2009 | ||||
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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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