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Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial

NCT00675025 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2021-03-29

Study results available
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Summary

The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.

Conditions

  • Down Syndrome

Interventions

DRUG

Donepezil hydrochloride (Aricept)

Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-04
Primary Completion
2008-11-13
Completion
2008-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00675025 on ClinicalTrials.gov