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

Novartis252 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

252

Conditions

ADHD, ADD

Interventions

Dexmethylphenidate HCl extended-release capsulesDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (25)

Novartis Investigational Site

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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