Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD|
- Change in attention and deportment measured at 2 hours post-dose
- Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
- Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
- Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
|Study Start Date:||May 2005|
|Study Completion Date:||July 2005|