NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
NCT01654250
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition
- Other serious illnesses or conditions that would put the patient at particular risk
for safety events or would interfere with treatment/assessment of ADHD
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Descriptive Information | ||||
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Brief Title ICMJE | NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD) | |||
Official Title ICMJE | 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 | |||
Brief Summary | The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Attention Deficit Hyperactivity Disorder | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Wigal SB, Childress A, Berry SA, Belden H, Walters F, Chappell P, Sherman N, Orazem J, Palumbo D. Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017 Oct;27(8):690-699. doi: 10.1089/cap.2016.0177. Epub 2017 May 30. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE | 90 | |||
Original Estimated Enrollment ICMJE | 80 | |||
Actual Study Completion Date ICMJE | October 2012 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 12 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01654250 | |||
Other Study ID Numbers ICMJE | NWP09-ADHD-300 B7491005 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |