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NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

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NCT01654250

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Clinical Study Centers, LLC
Little Rock, Arkansas, 72211 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
6-12 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this
condition

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

- Other serious illnesses or conditions that would put the patient at particular risk
for safety events or would interfere with treatment/assessment of ADHD

NCT01654250
Pfizer
Completed
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

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NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
A Multicenter, Dose-optimized, Double-blind, Randomized, Placebo-controlled Study To Evaluate The Efficacy Of Nwp09 In Pediatric Patients With Attention Deficit Hyperactivity Disorder (Adhd) In A Laboratory Classroom
The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD
Not Provided
Interventional
Phase 3
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: NWP09
    Methylphenidate, variable dose, daily dosing, 1 week duration
  • Drug: Placebo
    Placebo
  • Experimental: Active
    NWP09
    Intervention: Drug: NWP09
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion Criteria:

  • Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01654250
NWP09-ADHD-300
B7491005 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2016

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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