Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14

Novartis

Status and phase

Completed

Phase 3

Conditions

ADHD

Treatments

Drug: Methylphenidate hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00254878

CRIT124DDE01

Details and patient eligibility

About

Currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the other one by Medice (Germany).

The objective of the study is to test the hypothesis that the Novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by Medice.

Full description

The objective of the study is to test the hypothesis that the Novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by Medice.

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study:

Male and female patients aged 6-14.
Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnostic interview (Kiddie-Sads-Present and Lifetime Version)
Patients, whose symptoms are adequately controlled by a stable and well-tolerated dose of a immediate release methylphenidate equivalent of 20mg for one month before screening.

Exclusion criteria

Patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis).
Patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g.
- Tricyclic antidepressants, buproprion, clonidine, buspirone 2 weeks before randomization.
- Atomoxetine 2 weeks before randomization.
- Fluoxetine or antipsychotics 1 month before randomization.
- Pemoline and amphetamines 1 week before randomization.
Patients with a known non-response to methylphenidate.