MedTrace Logo

A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD

NCT03536390 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-11-01

No results posted yet for this study

Summary

This 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl) Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a sugar pill or placebo in children 4 to 5 years of age with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)

Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
48 Months
Max Age
69 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2021-04-22
Completion
2021-04-22
FDA Drug
Yes

More Related Trials

Entities

Drugs
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 NCT03536390 on ClinicalTrials.gov