Efficacy and Safety of SPD503 in Combination With Psychostimulants
NCT ID: NCT00734578
Last Updated: 2021-06-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
461 participants
INTERVENTIONAL
2008-09-02
2009-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
NCT00150618
Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17
NCT00152009
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
NCT00150592
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT00151996
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
NCT03260205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SPD503-AM
SPD503 (Guanfacine Extended Release)
SPD503-AM
SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg
SPD503-PM
SPD503 (Guanfacine Extended Release)
SPD503-PM
SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg
Placebo
Placebo
Placebo matched to Guanfacine Hydrochloride Extended Release
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPD503-AM
SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg
SPD503-PM
SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg
Placebo
Placebo matched to Guanfacine Hydrochloride Extended Release
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged 6-17 years with a sub-optimal
* Partial response to stimulants
* Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs
6 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shire
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Harmonex Neuroscience Research
Dothan, Alabama, United States
Melmed Center
Scottsdale, Arizona, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Valley Clinical Research, Inc.
El Centro, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
UCSD Department of Psychiatry
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Elite Clinical Trials, Inc
Wildomar, California, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
AMR-Baber Research, Inc.
Naperville, Illinois, United States
American Medical Research, Inc
Oak Brook, Illinois, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Pedia Research
Newburgh, Indiana, United States
Psychiatric Associates
Overland Park, Kansas, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
Marc Hertzman, MD, PC
Rockville, Maryland, United States
Delmarva Family Resources
Salisbury, Maryland, United States
Massachussests General Hospital
Cambridge, Massachusetts, United States
Neurobehaviorial Medicine
Bloomfield Hills, Michigan, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
Behavioral Medicine Center
Troy, Michigan, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Midwest Research Group/St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
Premier Psychiatric Research Inst. LLC
Lincoln, Nebraska, United States
Centers for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States
Children's Specialized Hospital
Toms River, New Jersey, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Duke University Medical Center ADHD Program
Durham, North Carolina, United States
Triangle Neuropsychiatry, PLLC
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Department of Psychiatry, The Ohio State University
Columbus, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc
Eugene, Oregon, United States
Oregon Center for Clinical Investigations, INC (OCCI, Inc.)
Portland, Oregon, United States
Summit Research Network
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc
Salem, Oregon, United States
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Peds Research Inc.
Barnwell, South Carolina, United States
FutureSearch Trials
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Western Clinical Investigations
Lubbock, Texas, United States
Cerebral Research, LLC
San Antonio, Texas, United States
Wharton Research Center
Wharton, Texas, United States
Vermont Clinical Study Center
Burlington, Vermont, United States
Psychiatric Alliance of the Blue Ridge Clinical Research
Charlottesville, Virginia, United States
NeuroScience, Inc
Herndon, Virginia, United States
Dominion Clinical Research
Midlothian, Virginia, United States
Alliance Research Group
Richmond, Virginia, United States
Bayou City Research
Richmond, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wilens TE, Bukstein O, Brams M, Cutler AJ, Childress A, Rugino T, Lyne A, Grannis K, Youcha S. A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):74-85.e2. doi: 10.1016/j.jaac.2011.10.012. Epub 2011 Nov 25.
Cutler AJ, Brams M, Bukstein O, Mattingly G, McBurnett K, White C, Rubin J. Response/remission with guanfacine extended-release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1092-101. doi: 10.1016/j.jaac.2014.08.001. Epub 2014 Aug 15.
Related Links
Access external resources that provide additional context or updates about the study.
FDA Recall Information
FDA-approved Label
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPD503-313
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.