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Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

This study has been completed.
Sponsor:
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

September 12, 2005
January 9, 2009
May 2004
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safety assessments
Same as current
Complete list of historical versions of study NCT00188812 on ClinicalTrials.gov Archive Site
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Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease
Open-Label, Multicentre, One Year Extension of the Evaluation of the Safety of Donepezil Hcl in Patients With Dementia Associated With Cerebrovascular Disease

one year extension study following a previous double-blind study to evaluate safety of the drug

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dementia Associated With Cerebrovascular Disease
Drug: donepezil hcl
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2005
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Inclusion Criteria:

  • must have completed previous study E2020-A001-319

Exclusion Criteria:

  • absence of a reliable caregiver
  • clinically significant medical condition
  • recent TIA
Both
45 Years and older
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Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00188812
03-0725-AE, E2020-A001-320
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University Health Network, Toronto
Eisai Inc.
Principal Investigator: Karl Farcnik, MD FRCP(C) University Health Network, Toronto
University Health Network, Toronto
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP