Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2009-04-06
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

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

Details

• Lead Sponsor: Shire
• Treatments: Lisdexamfetamine Dimesylate

Criteria

Inclusion Criteria:

• Meet DSM-IV-TR criteria for a primary diagnosis of ADHD

• Baseline ADHD-RS-IV score >=28

• BP w/in 95th percentile for age, gender, and height

Exclusion Criteria:

• Subject has controlled or uncontrolled comorbid psychiatric diagnosis

• Subject has conduct disorder

• Suicidal

• Under or overweight

• Concurrent chronic or acute illness that might confound results.