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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New River Pharmaceuticals
• Collaborator: Shire
• Treatments: Lisdexamfetamine Dimesylate

Criteria

Inclusion Criteria:

• primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria

• functioning at age appropriate levels intellectually

• blood pressure measurements within the 95th percentile for their gender, height and age

• ECG results are within the normal range

Exclusion Criteria:

• comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations

• history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder

• weighs less than 55 lbs (25 kg)or is significantly overweight or obese

• clinically significant ECG abnormality

• documented allergy or intolerance to amphetamines