Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478205
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2007-05-22
Brief Title:
Comparison of 23 mg Donepezil Sustained Release SR to 10 mg Donepezil Immediate Release IR in Patients With Moderate to Severe Alzheimers Disease
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Double-Blind Parallel-Group Comparison of 23 mg Donepezil Sustained Release SR to 10 mg Donepezil Immediate Release IR in Patients With Moderate to Severe Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare 23 mg donepezil sustained release SR to the currently marketed formulation of 10 mg donepezil immediate release IR in patients with moderate to severe Alzheimers disease
Detailed Description:
This study consists of a double-blind double-dummy parallel-group comparison of 23 mg donepezil SR with the currently marketed donepezil formulation 10 mg donepezil IR in patients with moderate to severe Alzheimers disease Patients must have been taking 10 mg IR or a bioequivalent generic for at least 3 months prior to Screening The study will consist of 24 weeks of daily administration of study medication with clinic visits at Screening Baseline 3 weeks safety only 6 weeks 12 weeks 18 weeks and 24 weeks or early termination Patients will receive either 10 mg donepezil IR in combination with the placebo corresponding to 23 mg donepezil SR or 23 mg donepezil SR in combination with the placebo corresponding to 10 mg donepezil IR
A total of approximately 1600 patients will be enrolled to obtain complete data from approximately 1200 completed patients Revised per Amendment 02 During the Baseline visit patients will be randomized in a 21 ratio 23 mg donepezil SR to 10 mg donepezil IR The study will be performed at approximately 200 global sites Asia Oceania Europe India Israel North America South Africa and South America Revised per Amendments 01 and 02 An Independent Data Monitoring Committee IDMC will be established to review safety aspects of the study and to evaluate the results of a planned interim analysis
Patients who complete the study may be eligible to undergo evaluation for enrollment into the open-label extension study E2020-G000-328
A total of approximately 1600 patients will be enrolled to obtain complete data from approximately 1200 completed patients Revised per Amendment 02 During the Baseline visit patients will be randomized in a 21 ratio 23 mg donepezil SR to 10 mg donepezil IR The study will be performed at approximately 200 global sites Asia Oceania Europe India Israel North America South Africa and South America Revised per Amendments 01 and 02 An Independent Data Monitoring Committee IDMC will be established to review safety aspects of the study and to evaluate the results of a planned interim analysis
Patients who complete the study may be eligible to undergo evaluation for enrollment into the open-label extension study E2020-G000-328
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 |
|---|---|---|---|
| 2006-004888-54 | EUDRACT_NUMBER | None | None |