NCT00301236

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (planned)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: —

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.

Conditions

• ADHD, ADD

Interventions

Type	Name	Description
DRUG	Dexmethylphenidate HCl extended-release capsules

Timeline

• Start date: 2006-02-01
• Completion: 2006-11-01
• First posted: 2006-03-10
• Last updated: 2007-12-21

Locations

25 sites across 1 country: United States