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NCT00478205 · ClinicalTrials.gov registry record · Phase 3

Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease

A Phase 3 study of Alzheimers Disease, sponsored by Eisai.

Completed
Registry status
Phase 3
Development phase
1,467
Enrollment target
1
Study location

NCT00478205 is a Phase 3 study of Alzheimers Disease that has completed, run by Eisai. The registered enrollment target is 1,467 participants, below the 4,051-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00478205, a Phase 3 study of Alzheimers Disease, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 3
Development phase
1,467 participants
Enrollment target
1
Study location

Study 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 Alzheimer's disease.

Conditions Studied

Alzheimers Disease

Interventions

  • DRUG Aricept (donepezil SR 23 mg)
  • DRUG Aricept (donepezil IR 10 mg)

Study Locations (1)

North Carolina

  • MedTrials, Inc. - Hickory

Trial Details

FieldValue
Enrollment Target 1,467 participants
Start Date 2007-06
Phase Phase 3

Sponsor

Eisai

287 total trials

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What the Registry Record Tells You About NCT00478205

The ClinicalTrials.gov registry entry for NCT00478205 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,467 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,051-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (64% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Aricept (donepezil SR 23 mg) is the first listed.

NCT00478205 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00478205 about?

NCT00478205 is a clinical study titled "Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease". 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 Alzheimer's disease.

What is the current status of trial NCT00478205?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,467 participants. The study started on 2007-06.

What conditions does trial NCT00478205 study?

This clinical trial studies the following conditions: Alzheimers Disease.

What interventions are being tested in trial NCT00478205?

The interventions under investigation include: Aricept (donepezil SR 23 mg) (DRUG), Aricept (donepezil IR 10 mg) (DRUG).

Who is sponsoring clinical trial NCT00478205?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00478205 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.