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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00735371

Public ClinicalTrials.gov record NCT00735371. 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 Sep 4, 2026, 11:17 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 III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Brief summary

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

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

Study identification

NCT ID
NCT00735371
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
314 participants

Conditions and interventions

Eligibility (public fields only)

Age range
13 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
Oct 7, 2008
Primary completion
Apr 5, 2009
Completion
Apr 5, 2009
Last update posted
Jun 13, 2021

2008 – 2009

United States locations

U.S. sites
45
U.S. states
24
U.S. cities
43
Facility City State ZIP Site status
Clinical Study Centers, LLC Little Rock Arkansas 72205
Valley Clinical Research, Inc. El Centro California 92243
Peninsula Research Associates, Inc Rolling Hills Estates California 90274
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute) San Diego California 92108
Elite Clinical Trials, Inc Wildomar California 92595
Florida Clinical Research Center, LLC Bradenton Florida 34208
Sarkis Clinical Trials Gainesville Florida 32607
Amedica Research Institute, Inc. Hialeah Florida 33013
Clinical Neuroscience Solutions, Inc. Jacksonville Florida 32216
Clinical Neuroscience Solutions, Inc. Orlando Florida 32806-1122
Miami Research Associates South Miami Florida 33143
Janus Center for Psychiatric Research West Palm Beach Florida 33407
Atlanta Center for Medical Research Atlanta Georgia 30308
Northwest Behavioral Research Center Marietta Georgia 30060
Capstone Clinical Research Libertyville Illinois 60048
Clinco Inc. Terre Haute Indiana 47802
Cientifica, Inc at Prairie View Newton Kansas 67114
Psychiatric Associates Overland Park Kansas 66211
Vince and Associates Clinical Research, Inc. Overland Park Kansas 66212
Pedia Research, LLC Owensboro Kentucky 42301
Four Rivers Clinical Research, Inc. Paducah Kentucky 42003
Louisiana Research Associates, Inc New Orleans Louisiana 70114
Bart Sangal, MD Troy Michigan 48085
Center for Psychiatry and Behavioral Medicine, Inc Las Vegas Nevada 89128
Children's Specialized Hospital Toms River New Jersey 08755
Bioscience Research, LLC Mount Kisco New York 10549
Triangle Neuropsychiatry, PLLC Durham North Carolina 27707
Innovis Health/Odyssey Research Fargo North Dakota 58104
University Hospitals of Cleveland Division of Child Adolescent Psychiatry Cleveland Ohio 44106
IPS Research Company Oklahoma City Oklahoma 73103
OCCI Eugene Oregon 97401
Summit Research Network Portland Oregon 97210
OCCI Inc Salem Oregon 97301
CRI Worldwide Philadelphia Pennsylvania 19139
Youth and Family Research Program/WP IC ADHD Research Program Pittsburgh Pennsylvania 15213
Valerie Arnold Memphis Tennessee 38119
FutureSearch Trials Austin Texas 78756
Bayou City Research, Ltd Houston Texas 77007
Red Oak Psychiatry Associates, PA Houston Texas 77090
ADHD Clinic of San Antonio San Antonio Texas 78247
Vermont Clinical Study Center Burlington Vermont 05401
Neuropsychiatric Associates Woodstock Vermont 05091
Neuroscience, Inc Herndon Virginia 20170
Dominion Clinical Research Midlothian Virginia 23112
Northwest Clinical Research Center Bellevue Washington 98004

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00735371, 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 13, 2021 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00735371 live on ClinicalTrials.gov.

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