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

• Status: Completed
• Trial end date: 2004-10-07
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Shire
• Treatments: Guanfacine

Criteria

Inclusion Criteria:

• Subjects with a primary diagnosis of ADHD

• Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test

• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

• Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders

• Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35

• Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder

• Subject is pregnant or lactating