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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01106430

Public ClinicalTrials.gov record NCT01106430. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01106430
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
267 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 28, 2010 (Actual)
Primary completion
Jul 19, 2012 (Actual)
Completion
Jul 19, 2012 (Actual)
Last update posted
Jun 11, 2021

2010 – 2012

United States locations

U.S. sites
34
U.S. states
25
U.S. cities
34
Facility City State ZIP Site status
Harmonex Neuroscience Research, Inc Dothan Alabama 36303 —
Clinical Study Centers, LLC Little Rock Arkansas 72205 —
Shanti Clinical Trials Colton California 92324 —
Psychiatric Centers at San Diego Feighner Research San Diego California 92108 —
Elite Clinical Trials, Inc. Wildomar California 92595 —
Sarkis Clinical Trials Gainesville Florida 32607 —
Amedica Research Institute, Inc. Hialeah Florida 33013 —
Fidelity Clinical Research, Inc. Lauderhill Florida 33319 —
Clinical Neuroscience Solutions, INC Orlando Florida 32806 —
Northwest Behavioral Research Center Roswell Georgia 30076 —
Capstone Clinical Research Libertyville Illinois 60048 —
Baber Psychiatric Associates Naperville Illinois 60563 —
Clinco Terre Haute Indiana 47802 —
Heartland Research Associates, LLC Wichita Kansas 67207 —
Four Rivers Clinical Research, Inc Paducah Kentucky 42003 —
Louisianna Research Associates New Orleans Louisiana 70114 —
Office of Marc Hertzman, MD, PC Rockville Maryland 20852 —
Rochester Center for Behavioral Medicine Rochester Hills Michigan 48307 —
Midwest Research Group/Saint Charles Psychiatric Associates Saint Charles Missouri 63301 —
Premier Psychiatric Research Institute, LLC Lincoln Nebraska 68526 —
Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada 89128 —
Children's Specialized Hospital Toms River New Jersey 08755 —
Richmond Behavioral Associates Staten Island New York 10312 —
Triangle Neuropsychiatry, PLLC Durham North Carolina 27707 —
Innovis Health Fargo North Dakota 58103 —
IPS Research Company Oklahoma City Oklahoma 73103 —
Cyn3rgy Research Gresham Oregon 97030 —
CRI Worldwide, LLC Kirkbride Division Philadelphia Pennsylvania 19139 —
Future Search Clinical Trials Austin Texas 78731 —
Red Oak Psychiatry Association, PA Houston Texas 77090 —
Western Clinical Investigations Lubbock Texas 79423 —
Cerebral Research, LLC San Antonio Texas 78247 —
Lifetree Clinical Research Salt Lake City Utah 84106 —
Eastside Therapeutic Resource Kirkland Washington 98033 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01106430, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 11, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01106430 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →