NCT00254878

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

A 7 Week Multicenter, Double-Blind, Randomized, Placebo-Controlled Cross-Over Evaluation of the Efficacy and Safety of Two Different Brands of Modified-Release Oral Dosage Forms of Methylphenidate-HCl (20 mg, q.d.) in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (planned)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Methylphenidate hydrochloride

Timeline

• Start date: 2005-10-01
• Completion: 2006-02-01
• First posted: 2005-11-17
• Last updated: 2007-12-21

Locations

1 site across 1 country: Germany