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

Last updated on August 9, 2018

FOR MORE INFORMATION
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
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.
Show details

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. Participation in a school type program (day care, preschool, kindergarten,
transitional kindergarten, or elementary school) for at least >/=2 half days of the
week for at least 3 months and that is anticipated to continue during the study.

8. 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.
Show details

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 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.

NCT03536390
Pfizer
Not yet recruiting
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD

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A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Methylphenidate Hydrochloride (Hcl) Extended Release Chewable Tablet (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
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.
Phase 4 Double-blind, Randomized, Parallel Group, Placebo-controlled Study of the Efficacy And Safety of Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind, placebo-controlled, parallel group study.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Double-blind

Primary Purpose: Treatment

Attention Deficit Hyperactivity Disorder
  • Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
    Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo
    one chewable tablet once daily in morning.
    Intervention: Drug: Placebo
  • Experimental: Methylphenidate Hydrochloride Extended Release Chewable Tablet
    one chewable tablet once daily in morning.
    Intervention: Drug: Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
Same as current
January 2021
January 2021   (Final data collection date for primary outcome measure)

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
  7. Participation in a school type program (day care, preschool, kindergarten, transitional kindergarten, or elementary school) for at least >/=2 half days of the week for at least 3 months and that is anticipated to continue during the study.
  8. 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 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.
Sexes Eligible for Study: All
48 Months to 69 Months   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03536390
B7491017
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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