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NCT00566501 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease
A Phase 3 study of Alzheimers Disease, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 915
- Enrollment target
- 1
- Study location
NCT00566501: Completed Phase 3 study of Alzheimers Disease, sponsored by Eisai.
NCT00566501 is a Phase 3 study of Alzheimers Disease that has completed, run by Eisai. The registered enrollment target is 915 participants, below the 3,920-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00566501, a Phase 3 study of Alzheimers Disease, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 915 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse events (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label extension study.
Primary Outcome
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, a change in treatment, or discontinuation of study drug, recu
Conditions Studied
Interventions
- DRUG Donepezil
Study Locations (1)
California
- Apex Research Institute - Santa Ana
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 915 participants |
| Start Date | 2007-12-14 |
| Est. Completion | 2010-04-01 |
| Phase | Phase 3 |
What the finished NCT00566501 record still lists
NCT00566501 is an interventional study that assigns participants to a tested intervention. The registered 915 participants enrollment target is mid-sized for trials with a published cap, below the 3,920-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 1 intervention - of which Donepezil is the first listed.
NCT00566501 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00566501 about?
NCT00566501 is a clinical study titled "Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease". The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse...
What is the current status of trial NCT00566501?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 915 participants. The study started on 2007-12-14. Estimated completion is 2010-04-01.
What conditions does trial NCT00566501 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT00566501?
The interventions under investigation include: Donepezil (DRUG).
Who is sponsoring clinical trial NCT00566501?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00566501 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00566501's enrollment target sits among peer trials
915 16th of 147 higher than 132 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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