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Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD. | Clinical Trials | Clareo Health

WITHDRAWNPHASE4

Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

A Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)

NCT03546400•Pfizer

View on ClinicalTrials.gov

Summary

2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.

Detailed Description

Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility

Age

4 - 5 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female child 4-5 years of age at screening.
•2. Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable)
•3. Meets DSM-5 criteria for ADHD based on the K-SADS-PL.
•4. ADHD RS-IV Preschool-Home Version score at Screening and Baseline \>/= 90th percentile for gender and age in \>/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
•5. Peabody Picture Vocabulary Test 4 (PPVT-4)Standard Score \>/=70.
•6. Child Global Assessment Scale (CGAS) score \</= 55.
•7. History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator.

Exclusion Criteria

•1. Treated with atomoxetine within 30 days prior to the Baseline.
•2. Received any investigational products or devices within 30 days prior to the Baseline visit.
•3. History of stimulant nonresponse, intolerability or hypersensitivity to any dose of methylphenidate or other stimulant.If a subject has a known allergy to D\&C red #30, he/she should not be enrolled in the study.
•4. An intelligence quotient (IQ) \<70.
•5. History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
•6. Less than 5th percentile for height or weight at Screening.
•7. History of recent clinically significant self-harming behaviors.

Key Dates

Start Date

September 25, 2018

Primary Completion Date

December 3, 2020

Completion Date

December 3, 2020

Last Updated

November 1, 2018

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

methylphenidate HCl ERCT

DRUG

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

Inclusion Criteria

Exclusion Criteria

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