NCT00556296

Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD

A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: New River Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	NRP104	NRP104 30mg capsule once daily in a.m.
DRUG	NRP104	NRP104 50mg capsule once daily in a.m.
DRUG	NRp104	NRP104 70mg capsule once daily in a.m.
DRUG	Placebo	Placebo

Timeline

• Start date: 2004-10-01
• Completion: 2005-09-01
• First posted: 2007-11-09
• Last updated: 2011-06-21