Efficacy and Safety of SPD503 in Combination With Psychostimulants

Completed · Phase 3 · Has a placebo group

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT00734578

Run by

Shire

People needed

461

Starts

2008-09-02

Expected to finish

2009-12-10

Last updated by the study team

2021-06-14

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
• Aged 6-17 years with a sub-optimal
• Partial response to stimulants
• Subjects must be < 95th percentile for BMI with weight >= 55lbs and <= 176lbs

Where it is running

• 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
• Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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