Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder

Completed · Phase 3

Conditions studied: ADHD, ADD

In brief

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.

Key facts

Study ID

NCT00301236

Run by

Novartis

People needed

252

Starts

2006-02-01

Expected to finish

2006-11-01

Last updated by the study team

2007-12-21

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigational Site — Mesa, Arizona, United States
• Novartis Investigational Site — Little Rock, Arkansas, United States
• Novartis Investigational Site — Los Angeles, California, United States
• Novartis Investigational Site — Boulder, Colorado, United States
• Novartis Investigational Site — Maitland, Florida, United States
• Novartis Investigational Site — Orlando, Florida, United States
• Novartis Investigational Site — Stone Mountain, Georgia, United States
• Novartis Investigational Site — Libertyville, Illinois, United States
• Novartis Investigational Site — Overland Park, Kansas, United States
• Novartis Investigational Site — Prairie Village, Kansas, United States
• Novartis Investigational Site — Cambridge, Massachusetts, United States
• Novartis Investigational Site — Las Vegas, Nevada, United States
• Novartis Investigational Site — Piscataway, New Jersey, United States
• Novartis Investigational Site — Toms River, New Jersey, United States
• Novartis Investigational Site — New York, New York, United States
• Novartis Investigational Site — New York, New York, United States
• Novartis Investigational Site — Staten Island, New York, United States
• Novartis Investigational Site — Chapel Hill, North Carolina, United States
• Novartis Investigational Site — Raleigh, North Carolina, United States
• Novartis Investigational Site — Columbus, Ohio, United States
• Novartis Investigational Site — Gresham, Oregon, United States
• Novartis Investigational Site — Philadelphia, Pennsylvania, United States
• Novartis Investigational Site — Jackson, Tennessee, United States
• Novartis Investigational Site — Memphis, Tennessee, United States
• Novartis Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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