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NCT00428389 · ClinicalTrials.gov registry record · Phase 3
Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
NCT00428389 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 262 participants.
The verdict
NCT00428389, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
Study Summary
This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm\^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period.
Interventions
- DRUG Rivastigmine 5 cm^2 transdermal patch
- DRUG Rivastigmine 10 cm^2 transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00428389
The ClinicalTrials.gov registry entry for NCT00428389 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 262 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rivastigmine 5 cm^2 transdermal patch is the first listed.
NCT00428389 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00428389 about?
NCT00428389 is a clinical study titled "Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease". This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm\^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-la...
What is the current status of trial NCT00428389?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2007-01. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00428389?
The interventions under investigation include: Rivastigmine 5 cm^2 transdermal patch (DRUG), Rivastigmine 10 cm^2 transdermal patch (DRUG).
Who is sponsoring clinical trial NCT00428389?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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