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NCT00948766 · ClinicalTrials.gov registry record · Phase 4
Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44
A Phase 4 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 716
- Enrollment target
NCT00948766 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 716 participants.
The verdict
NCT00948766, a Phase 4 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 716 participants
- Enrollment target
Study Summary
The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm\^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm\^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks.
Interventions
- DRUG Placebo
- DRUG Rivastigmine 4.6 mg/24 h (5 cm^2)
- DRUG Rivastigmine 9.5 mg/24 h (10 cm^2)
- DRUG Rivastigmine 13.3 mg/24 h (15 cm^2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 716 participants |
| Start Date | 2009-07 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00948766
The ClinicalTrials.gov registry entry for NCT00948766 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 716 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 4 interventions - of which Placebo is the first listed.
NCT00948766 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00948766 about?
NCT00948766 is a clinical study titled "Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44". The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm\^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm\^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study ob...
What is the current status of trial NCT00948766?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 716 participants. The study started on 2009-07. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00948766?
The interventions under investigation include: Placebo (DRUG), Rivastigmine 4.6 mg/24 h (5 cm^2) (DRUG), Rivastigmine 9.5 mg/24 h (10 cm^2) (DRUG), Rivastigmine 13.3 mg/24 h (15 cm^2) (DRUG).
Who is sponsoring clinical trial NCT00948766?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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