Official Title: “A Phase III, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)”

The purpose of this study is to assess the safety and efficacy of SPD503 compared to placebo in the treatment of ADHD in children and adolescents aged 6-17

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

• ADHD-RS score at 7 weeks

Secondary Measures

• CPRS-R scale
• CTRS-R scale
• CGI-I
• Parent's global assessment
• Child health Questionnaire

Inclusion Criteria:

• Subjects with a primary diagnosis of ADHD
• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

• Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms
• History of seizure during the last 2 years
• Subject has any specific cardiac condition or family history of significant cardiac condition
• Subject is pregnant or lactating

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/NCT00152009

Study ID Number: SPD503-301

ClinicalTrials.gov Identifier: NCT00152009

Health Authority: United States: Food and Drug Administration