NCT01106430

Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel Group Study to Assess the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine Dimesylate	Oral 30, 50, or 70mg once-daily for 9 weeks
DRUG	Atomoxetine Hydrochloride	Oral 10mg to 100mg once-daily for 9 weeks

Timeline

• Start date: 2010-06-28
• Primary completion: 2012-07-19
• Completion: 2012-07-19
• First posted: 2010-04-19
• Last updated: 2021-06-11
• Results posted: 2013-06-24

Locations

64 sites across 10 countries: United States, Belgium, Canada, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom