Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT00735371
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
314 participants
INTERVENTIONAL
2008-10-08
2009-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lisdexamfetamine Dimesylate (LDX) 30 mg
LDX 30 mg
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
LDX 50 mg
LDX 50 mg
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
LDX 70 mg
LDX 70 mg
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
Placebo
Placebo
Placebo will be identical to test product.
Interventions
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LDX 70 mg
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
Placebo
Placebo will be identical to test product.
LDX 30 mg
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
LDX 50 mg
Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Baseline ADHD-RS-IV score \>=28
* BP w/in 95th percentile for age, gender, and height
Exclusion Criteria
* Subject has conduct disorder
* Suicidal
* Under or overweight
* Concurrent chronic or acute illness that might confound results.
13 Years
17 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Bioscience Research, LLC
Mount Kisco, New York, United States
Triangle Neuropsychiatry, PLLC
Durham, North Carolina, United States
Innovis Health/Odyssey Research
Fargo, North Dakota, United States
University Hospitals of Cleveland Division of Child Adolescent Psychiatry
Cleveland, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
OCCI
Eugene, Oregon, United States
Summit Research Network
Portland, Oregon, United States
OCCI Inc
Salem, Oregon, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Youth and Family Research Program/WP IC ADHD Research Program
Pittsburgh, Pennsylvania, United States
Valerie Arnold
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
Bayou City Research, Ltd
Houston, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
ADHD Clinic of San Antonio
San Antonio, Texas, United States
Vermont Clinical Study Center
Burlington, Vermont, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
Neuroscience, Inc
Herndon, Virginia, United States
Dominion Clinical Research
Midlothian, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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References
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Findling RL, Childress AC, Cutler AJ, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):395-405. doi: 10.1016/j.jaac.2011.01.007. Epub 2011 Mar 3.
Related Links
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FDA recall information
Other Identifiers
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SPD489-305
Identifier Type: -
Identifier Source: org_study_id
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