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

Completed · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)

In brief

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

Key facts

Study ID

NCT00735371

Run by

Shire

People needed

314

Starts

2008-10-08

Expected to finish

2009-04-06

Last updated by the study team

2021-06-14

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
• Baseline ADHD-RS-IV score >=28
• BP w/in 95th percentile for age, gender, and height

You may not qualify if…

• Subject has controlled or uncontrolled comorbid psychiatric diagnosis
• Subject has conduct disorder
• Suicidal
• Under or overweight
• Concurrent chronic or acute illness that might confound results.

Where it is running

• Clinical Study Centers, LLC — Little Rock, Arkansas, United States
• Valley Clinical Research, Inc. — El Centro, California, United States
• Peninsula Research Associates, Inc — Rolling Hills Estates, California, United States
• Psychiatric Centers at San Diego (PCSD-Feighner Research Institute) — San Diego, California, United States
• Elite Clinical Trials, Inc — Wildomar, California, United States
• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Amedica Research Institute, Inc. — Hialeah, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Janus Center for Psychiatric Research — West Palm Beach, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Northwest Behavioral Research Center — Marietta, Georgia, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Clinco Inc. — Terre Haute, Indiana, United States
• Cientifica, Inc at Prairie View — Newton, Kansas, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Vince and Associates Clinical Research, Inc. — Overland Park, Kansas, United States
• Pedia Research, LLC — Owensboro, Kentucky, United States
• Four Rivers Clinical Research, Inc. — Paducah, Kentucky, United States
• Louisiana Research Associates, Inc — New Orleans, Louisiana, United States
• Bart Sangal, MD — Troy, Michigan, United States
• Center for Psychiatry and Behavioral Medicine, Inc — Las Vegas, Nevada, United States
• Children's Specialized Hospital — Toms River, New Jersey, United States

Full record on ClinicalTrials.gov

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