Trials / Completed
CompletedNCT00566501
Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease
Open-Label Extension Study of 23 mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 915 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 45 Years – 91 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Donepezil | Donepezil SR 23 mg once daily orally. |
Timeline
- Start date
- 2007-12-14
- Primary completion
- 2010-04-01
- Completion
- 2010-04-01
- First posted
- 2007-12-03
- Last updated
- 2021-11-17
- Results posted
- 2012-06-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00566501. Inclusion in this directory is not an endorsement.