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

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Attention Deficit Hyperactivity Disorder (ADHD)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
48-69 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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)

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.

NCT03546400
Pfizer
Withdrawn
Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

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