Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00036114 |
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Recruitment Status :
Completed
First Posted : May 9, 2002
Last Update Posted : November 11, 2013
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Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2002 | ||
| First Posted Date ICMJE | May 9, 2002 | ||
| Last Update Posted Date | November 11, 2013 | ||
| Study Start Date ICMJE | March 2000 | ||
| Actual Primary Completion Date | August 2003 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE | Not Provided | ||
| Original Primary Outcome Measures ICMJE | Not Provided | ||
| Change History | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type | ||
| Official Title ICMJE | Not Provided | ||
| Brief Summary | The purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 3 | ||
| Study Design ICMJE | Primary Purpose: Treatment | ||
| Condition ICMJE | Alzheimer Disease | ||
| Intervention ICMJE | Drug: aripiprazole | ||
| Study Arms ICMJE | 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 | Not Provided | ||
| Original Enrollment ICMJE | Not Provided | ||
| Actual Study Completion Date ICMJE | August 2003 | ||
| Actual Primary Completion Date | August 2003 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 55 Years to 95 Years (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00036114 | ||
| Other Study ID Numbers ICMJE | CN138-004 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
| Verification Date | April 2011 | ||
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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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