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NCT00570128 · ClinicalTrials.gov registry record · Phase 2

Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome

A Phase 2 study, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
129
Enrollment target

NCT00570128 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 129 participants.

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The verdict

NCT00570128, a Phase 2 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
129 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome (DS). Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to 17.

Interventions

  • DRUG Placebo
  • DRUG Donepezil HCl

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2007-11-16
Est. Completion 2008-09-05
Phase Phase 2

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT00570128

The ClinicalTrials.gov registry entry for NCT00570128 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00570128 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00570128 about?

NCT00570128 is a clinical study titled "Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome". The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome (DS). Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in ...

What is the current status of trial NCT00570128?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2007-11-16. Estimated completion is 2008-09-05.

What interventions are being tested in trial NCT00570128?

The interventions under investigation include: Placebo (DRUG), Donepezil HCl (DRUG).

Who is sponsoring clinical trial NCT00570128?

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

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.