Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17

• Status: Completed
• Trial end date: 2005-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Shire
• Treatments: Guanfacine

Criteria

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