Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
A 5-Week Treatment, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of the Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules Administered Once Daily in Pediatric Children With Attention-Deficit/Hyperactivity Disorder
1 other identifier
interventional
252
1 country
25
Brief Summary
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2006
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 8, 2006
CompletedFirst Posted
Study publicly available on registry
March 10, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedDecember 21, 2007
December 1, 2007
March 8, 2006
December 17, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.
Secondary Outcomes (4)
Assessment of the symptoms by the patient's parent after five weeks of treatment.
Change in severity of the illness assessed by the physician after 5 weeks of treatment
Improvement of the illness assessed by the physician after 5 weeks of treatment
Safety and tolerability of 5 week's treatment with dexmethylphenidate HCl extended-release capsules in children with Attention-Deficit/Hyperactivity Disorder by assessing the frequency of adverse findings
Interventions
Eligibility Criteria
You may qualify if:
- Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term
You may not qualify if:
- Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical condition other than ADHD; ADHD medication within a specified timeperiod prior to study start; Pregnancy or nursing; Positive drug screen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (25)
Novartis Investigational Site
Mesa, Arizona, 85210, United States
Novartis Investigational Site
Little Rock, Arkansas, 72205, United States
Novartis Investigational Site
Los Angeles, California, 90095, United States
Novartis Investigational Site
Boulder, Colorado, 80304, United States
Novartis Investigational Site
Maitland, Florida, 32751, United States
Novartis Investigational Site
Orlando, Florida, 32806, United States
Novartis Investigational Site
Stone Mountain, Georgia, 30083, United States
Novartis Investigational Site
Libertyville, Illinois, 60048, United States
Novartis Investigational Site
Overland Park, Kansas, 66211, United States
Novartis Investigational Site
Prairie Village, Kansas, 66206, United States
Novartis Investigational Site
Cambridge, Massachusetts, 02138, United States
Novartis Investigational Site
Las Vegas, Nevada, 89128, United States
Novartis Investigational Site
Piscataway, New Jersey, 08855, United States
Novartis Investigational Site
Toms River, New Jersey, 08755, United States
Novartis Investigational Site
New York, New York, 10029, United States
Novartis Investigational Site
New York, New York, 10032, United States
Novartis Investigational Site
Staten Island, New York, 10305, United States
Novartis Investigational Site
Chapel Hill, North Carolina, 27514, United States
Novartis Investigational Site
Raleigh, North Carolina, 27609, United States
Novartis Investigational Site
Columbus, Ohio, 43205, United States
Novartis Investigational Site
Gresham, Oregon, 97030, United States
Novartis Investigational Site
Philadelphia, Pennsylvania, 19149, United States
Novartis Investigational Site
Jackson, Tennessee, 38305, United States
Novartis Investigational Site
Memphis, Tennessee, 38119, United States
Novartis Investigational Site
Houston, Texas, 77007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 8, 2006
First Posted
March 10, 2006
Study Start
February 1, 2006
Study Completion
November 1, 2006
Last Updated
December 21, 2007
Record last verified: 2007-12