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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New River Pharmaceuticals
• Treatments: Adderall; Amphetamine; Lisdexamfetamine Dimesylate

Criteria

Inclusion Criteria:

• males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes

• on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects

Exclusion Criteria:

• co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder

• history of seizure during the last 2 years, a tic disorder or Tourette's

• clinically significant ECG or laboratory abnormalities at screening or baseline

• taking clonidine or anticonvulsant drugs

• taking medications that affect blood pressure or heart rate