Official Title: “A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)”

The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Guanfacine hydrochloride

Primary Measures

• 5-pt CRT (Choice Reaction Time) at 6 weeks

Secondary Measures

• DSST/Coding Test
• SWM assessment
• PERMP math test
• ADHD-RS-IV scale
• CGI-I scale

Inclusion Criteria:

• Subjects with a primary diagnosis of ADHD
• Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
• Subject weighs > 55 lbs and is not morbidly overweight

Exclusion Criteria:

• Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
• Subject has a history of seizure disorder
• Subject has any specific cardiac condition or family history of significant cardiac condition
• Subject is pregnant, lactating or within six month post-partum

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shire Pharmaceutical Development

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150592

Study ID Number: SPD503-206

ClinicalTrials.gov Identifier: NCT00150592

Health Authority: United States: Food and Drug Administration