Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
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 Sep 4, 2026, 4:31 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, 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 1, 2008
Primary completion
Dec 9, 2009
Completion
Dec 9, 2009
Last update posted
Jun 13, 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 13, 2021 · Synced Sep 4, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00734578 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →