Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease
This study has been completed.
Sponsor:
University Health Network, Toronto
Collaborator:
Eisai Inc.
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188812
First received: September 12, 2005
Last updated: January 9, 2009
Last verified: September 2005
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | January 9, 2009 | ||||
| Start Date ICMJE | May 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
safety assessments | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00188812 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease | ||||
| Official Title ICMJE | Open-Label, Multicentre, One Year Extension of the Evaluation of the Safety of Donepezil Hcl in Patients With Dementia Associated With Cerebrovascular Disease | ||||
| Brief Summary | one year extension study following a previous double-blind study to evaluate safety of the drug |
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| Detailed Description | A one year extension study for patients who completed E2020-A001-319. Patients will receive 5my donepezil daily for the first 8 weeks and will be assessed by the incidence of advere events, changes in physical exams, ECG and clinical lab determinations. The results will be assessed 6 timues during the year. After 8 week, the investigator may increase the dose to 10mg/day if the patient if the patients show satisfactory tolerability. Six psychometric scales will also be evaluatd. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Dementia Associated With Cerebrovascular Disease | ||||
| Intervention ICMJE | Drug: donepezil hcl | ||||
| 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 | Not Provided | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 45 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00188812 | ||||
| Other Study ID Numbers ICMJE | 03-0725-AE, E2020-A001-320 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE | Eisai Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | September 2005 | ||||
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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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