NCT00557011

NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Treatment, 3-Period, Crossover Study With One Week Per Treatment and Once-a-Day Dosing of Either NRP104, Adderall XR, or Placebo in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: New River Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	NRP104	30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
DRUG	Adderall XR	10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
DRUG	Placebo	Placebo capsule taken once daily in the morning

Timeline

• Start date: 2004-09-01
• Completion: 2004-12-01
• First posted: 2007-11-12
• Last updated: 2011-05-25