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

Novartis1 site in 1 country252 target enrollmentFebruary 2006

ConditionsADHD, ADD

DrugsDexmethylphenidate HCl extended-release capsules

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: ADHD, ADD
Sponsor: Novartis
Enrollment: 252
Locations: 1
Primary Endpoint: Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

November 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

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

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