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NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00904670
First received: May 18, 2009
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to determine whether NWP06 is effective in the treatment of ADHD in children ages 6-12.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: NWP06
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NWP06 in the Treatment of Children With ADHD: A Laboratory Classroom Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • SKAMP [ Time Frame: Weeks 5-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PERMP [ Time Frame: Weeks 5-6 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: May 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NWP06 Drug: NWP06
Once daily liquid
Placebo Comparator: Placebo Drug: Placebo
Once daily liquid

Detailed Description:

This is a randomized, double-blind, placebo-controlled, crossover design, optimized-dose, Phase 3 trial to evaluate the safety and efficacy of NWP06 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ADHD
  • In need of pharmacological treatment for ADHD

Exclusion Criteria:

  • Other psychiatric diagnoses
  • Significant cognitive impairment
  • Chronic medical illnesses
  • Structural cardiac defects
  • Significant abnormal lab tests
  • Taking disallowed medications
  • Positive drug test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904670

Locations
United States, California
University of California, Irvine Child Development Center
Irvine, California, United States
United States, Nevada
Dr Ann Childress
Las Vegas, Nevada, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Sally A Berry, MD, PhD Pfizer
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00904670     History of Changes
Other Study ID Numbers: NWP06-ADD-100
Study First Received: May 18, 2009
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013