Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
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ClinicalTrials.gov Identifier: NCT00036114 |
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 | |||
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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 | ||
* 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 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |