Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188812
Status:
COMPLETED
Last Update Posted:
2009-01-12
First Post:
2005-09-12
Brief Title:
Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Open-Label Multicentre One Year Extension of the Evaluation of the Safety of Donepezil Hcl in Patients With Dementia Associated With Cerebrovascular Disease
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
one year extension study following a previous double-blind study to evaluate safety of the drug
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 10mgday if the patient if the patients show satisfactory tolerability Six psychometric scales will also be evaluatd
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E2020-A001-320 | None | None | None |