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6 Month OL Study to Evaluate the Safety, Tolerability and Efficacy of Methylphenidate HCl ERCT in Children With ADHD.

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NCT03580005

Last updated on November 28, 2019
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Study Location
Contact
1-800-718-1021
[email protected]
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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
4-5 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male or female child who participated in B7491017 or B7491020.

2. Signed and dated informed consent provided by the subject's parent/legal and assent of
the child (as applicable).

3. Willing and able to comply with scheduled visit, treatment plan, laboratory tests and
other study procedures.

4. Sitting systolic or diastolic blood pressure (BP) height.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Clinically significant AEs or SAEs related to investigational product while
participating in study B7491017 or study B7491020 that would preclude treatment with
methylphenidate HCl ERCT.

2. Other acute or chronic medical or psychiatric condition that would make the patient
inappropriate for entry.

3. Use of prohibited concomitant treatments.

4. Poor compliance with investigational product or study procedures.

NCT03580005
Pfizer
Not yet recruiting
6 Month OL Study to Evaluate the Safety, Tolerability and Efficacy of Methylphenidate HCl ERCT in Children With ADHD.

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Descriptive Information
Brief Title  ICMJE A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
Official Title  ICMJE A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Brief SummaryA 6-week double-blind study to evaluate the safety and efficacy of Quillichew extended release chewable tablets in 4-5 year old children with attention deficit hyperactivity disorder.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: methylphenidate HCl ERCT
    methylphenidate HCl ERCT
  • Drug: Placebo
    Placebo to Match Quillichew ERCT
Study Arms  ICMJE
  • Active Comparator: Quillichew ERCT
    Quillichew ERCT
    Intervention: Drug: methylphenidate HCl ERCT
  • Placebo Comparator: Placebo to match Quillichew ERCT
    Placebo to match Quillichew ERCT
    Intervention: Drug: Placebo
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: July 5, 2018)		88
Estimated Study Completion Date  ICMJE October 12, 2021
Estimated Primary Completion DateOctober 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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

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 Quillichew ERCT or other stimulant.
  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 4 Years to 5 Years   (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 NCT03580005
Other Study ID Numbers  ICMJE B7491019
Has Data Monitoring CommitteeYes
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/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2018

ICMJE     Data element required by the

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

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