Efficacy and Safety of SPD503 in Combination With Psychostimulants

• Status: Completed
• Trial end date: 2009-12-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

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

Details

• Lead Sponsor: Shire
• Treatments: Guanfacine

Criteria

Inclusion Criteria:

• Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks

• Aged 6-17 years with a sub-optimal

• Partial response to stimulants

• Subjects must be < 95th percentile for BMI with weight >= 55lbs and <= 176lbs