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Completed

NCT Number: NCT00301236

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

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.

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Key information

Conditions

ADHD, ADD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigational Site, Mesa, Arizona, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term

Exclusion criteria

  • 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

Treatment and study plan

Dexmethylphenidate HCl extended-release capsules

Drug

Primary outcomes

  1. Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.

Secondary outcomes

  1. Assessment of the symptoms by the patient's parent after five weeks of treatment.

  2. Change in severity of the illness assessed by the physician after 5 weeks of treatment

  3. Improvement of the illness assessed by the physician after 5 weeks of treatment

  4. 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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
Mar 10, 2006
Registry last updated
Dec 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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