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

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NCT03546400

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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.
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

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.
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 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.

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Attention Deficit Hyperactivity Disorder (ADHD)Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
NCT03546400
ALL GENDERS
48 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
Official Title  ICMJE 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)
Brief 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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder (ADHD)
Intervention  ICMJE Drug: methylphenidate HCl ERCT
methylphenidate HCl ERCT
Study Arms  ICMJE methylphenidate HCl ERCT
methylphenidate HCl ERCT
Intervention: Drug: methylphenidate HCl ERCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)		0
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2018)		8
Estimated Study Completion Date  ICMJE December 3, 2020
Estimated Primary Completion Date December 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 48 Months to 69 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03546400
Other Study ID Numbers  ICMJE B7491020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP