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

Last updated on February 18, 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), Attention Deficit Hyperactivity Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-5 years
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 baseline.

2. Signed and dated informed consent document.

3. Meets DSM-V 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 (PPVT4)Standard Score >/=70.

6. Child Global Assessment Scale (CGAS) score = 55.

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
Quillichew ERCT or other stimulant.

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.

NCT03580005
Pfizer
Withdrawn
A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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