drugset / Trial / NCT01106430

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

NCT01106430

Phase 3 Completed 267 enrolled Shire
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-06-28
Primary completion
2012-07-19
Completion
2012-07-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atomoxetine Other / unclassified 10 mg Oral
Comparator Atomoxetine Other / unclassified 100 mg Oral
Subject Lisdexamfetamine Other / unclassified 30 mg Oral
Subject Lisdexamfetamine Other / unclassified 50 mg Oral
Subject Lisdexamfetamine Other / unclassified 70 mg Oral