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Completed Phase 3 Interventional Results available

Efficacy and Safety of SPD503 in Combination With Psychostimulants

ClinicalTrials.gov ID: NCT00734578

Public ClinicalTrials.gov record NCT00734578. 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 19, 2026, 9:43 PM 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, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of SPD503 in Combination With Psychostimulants in Children and Adolescents Aged 6-17 Years With a Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Brief summary

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

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

Study identification

NCT ID
NCT00734578
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
461 participants

Conditions and interventions

Conditions

Interventions

Drug

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
Sep 2, 2008 (Actual)
Primary completion
Dec 10, 2009 (Actual)
Completion
Dec 10, 2009 (Actual)
Last update posted
Jun 14, 2021

2008 – 2009

United States locations

U.S. sites
61
U.S. states
27
U.S. cities
56
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303 —
Melmed Center Scottsdale Arizona 85254 —
Clinical Study Centers, LLC Little Rock Arkansas 72205 —
Valley Clinical Research, Inc. El Centro California 92243 —
Peninsula Research Associates Rolling Hills Estates California 90274 —
UCSD Department of Psychiatry San Diego California 8620 —
University of California, San Francisco San Francisco California 94143 —
Elite Clinical Trials, Inc Wildomar California 92595 —
Florida Clinical Research Center, LLC Bradenton Florida 32751 —
Gulfcoast Clinical Research Center Fort Myers Florida 33912 —
Sarkis Clinical Trials Gainesville Florida 32607 —
Clinical Neuroscience Solutions, Inc. Jacksonville Florida 32216 —
Florida Clinical Research Center, LLC Maitland Florida 32751 —
Miami Children's Hospital Miami Florida 33155 —
Clinical Neuroscience Solutions, Inc. Orlando Florida 32806 —
Janus Center for Psychiatric Research West Palm Beach Florida 33407 —
AMR-Baber Research, Inc. Naperville Illinois 60563 —
American Medical Research, Inc Oak Brook Illinois 60523 —
Goldpoint Clinical Research, LLC Indianapolis Indiana 46260 —
Pedia Research Newburgh Indiana 47630 —
Psychiatric Associates Overland Park Kansas 66211 —
Vince and Associates Clinical Research Overland Park Kansas 66212 —
Pedia Research, LLC Owensboro Kentucky 42301 —
Marc Hertzman, MD, PC Rockville Maryland 20852 —
Delmarva Family Resources Salisbury Maryland 21801 —
Massachussests General Hospital Cambridge Massachusetts 02138 —
Neurobehaviorial Medicine Bloomfield Hills Michigan 48302 —
Rochester Center for Behavioral Medicine Rochester Hills Michigan 48307 —
Behavioral Medicine Center Troy Michigan 48083 —
The Center for Pharmaceutical Research Kansas City Missouri 64114 —
Midwest Research Group/St. Charles Psychiatric Associates Saint Charles Missouri 63301 —
Premier Psychiatric Research Inst. LLC Lincoln Nebraska 68510 —
Centers for Psychiatry and Behavioral Medicine Las Vegas Nevada 89128 —
Children's Specialized Hospital Toms River New Jersey 08755 —
Bioscience Research, LLC Mount Kisco New York 10549 —
Richmond Behavioral Associates Staten Island New York 10312 —
Duke University Medical Center ADHD Program Durham North Carolina 27705 —
Triangle Neuropsychiatry, PLLC Durham North Carolina 27707 —
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 —
Department of Psychiatry, The Ohio State University Columbus Ohio 43210 —
IPS Research Oklahoma City Oklahoma 73103 —
Oregon Center for Clinical Investigations, Inc Eugene Oregon 97401 —
Oregon Center for Clinical Investigations, INC (OCCI, Inc.) Portland Oregon 97210 —
Summit Research Network Portland Oregon 97210 —
Oregon Center for Clinical Investigations, Inc Salem Oregon 97301 —
Western Psychiatric Institute and Clinic Pittsburgh Pennsylvania 15065 —
Peds Research Inc. Barnwell South Carolina 29812 —
FutureSearch Trials Austin Texas 75756 —
InSite Clinical Research DeSoto Texas 75115 —
Claghorn-Lesem Research Clinic, Inc. Houston Texas 77008 —
Red Oak Psychiatry Associates, PA Houston Texas 77090 —
Western Clinical Investigations Lubbock Texas 79423 —
Cerebral Research, LLC San Antonio Texas 78247 —
Wharton Research Center Wharton Texas 77488 —
Vermont Clinical Study Center Burlington Vermont 05401 —
Psychiatric Alliance of the Blue Ridge Clinical Research Charlottesville Virginia 22903 —
NeuroScience, Inc Herndon Virginia 20170 —
Dominion Clinical Research Midlothian Virginia 23112 —
Alliance Research Group Richmond Virginia 23230 —
Bayou City Research Richmond Virginia 23230 —
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 NCT00734578, 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 14, 2021 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00734578 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →