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

Last updated on July 11, 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 (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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6 Month OL Study to Evaluate the Safety, Tolerability and Efficacy of Methylphenidate HCl ERCT in Children With ADHD.
A Phase 4, 6-month Open-label Extension Study To Evaluate The Safety, Tolerability And Efficacy Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In Children With Attention Deficit Hyperactivity Disorder (Adhd) Who Participated In Study B7491017 Or Study B7491020.
6-month open label study to evaluate the safety, tolerability and efficacy of methylphenidate HCl ERCT in children with ADHD
6 month open label study to evaluate the safety, tolerability and efficacy of methylphenidate HCl ERCT in preschool aged children with ADHD who participated in study B7491017 or B7491020.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder (ADHD)
Drug: methylphenidate HCl ERCT
methylphenidate HCl ERCT
methylphenidate HCl ERCT
methylphenidate HCl ERCT
Intervention: Drug: methylphenidate HCl 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
88
Same as current
October 12, 2021
October 12, 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  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) <95th percentile for age, sex, and height.

Exclusion Criteria:

  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.
Sexes Eligible for Study: All
4 Years to 5 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03580005
B7491019
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
June 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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