Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.

First Received: July 19, 2007 Last Updated: March 30, 2009 History of Changes

Sponsor:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00507065

Purpose

Assess the safety and efficacy of ADDERALL XR compared to placebo in the treatment of adolescents (aged 13-17) with ADHD. Subjects were assigned to one of two cohorts based on weight (<= 75 kg or > 75 kg).

Condition	Intervention	Phase
ADHD	Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of ADDERALL XR With an Open Label Extension, in the Treatment of Adolescents Aged 13-17 With ADHD

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Amphetamine

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Change from baseline to final visit of the double-blind phase of the study in the ADHD-RS-IV score in the cohort weighing less than or equal to 75 kg. [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to final visit of double-blind phase of the study in ADHD-RS-IV score in the cohort weighing >75 kg and the CGI for ADHD in both cohorts. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
Adverse events, labs, physical exam, ECG [ Time Frame: approximately 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	329
Study Start Date:	May 2003
Study Completion Date:	April 2004

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males/females 13-17 years of age meeting DSM-IV criteria for a primary diagnosis of ADHD

Exclusion Criteria:

Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD
Known non-responder to stimulant medication
Documented allergy or intolerance to ADDERALL, ADDERALL XR or amphetamines
Conduct Disorder, hypertension, history of seizure
Tic disorder or Tourette's disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507065

Locations

United States, New York
New York University - Child Study Center
New York, New York, United States

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Study Director:

Raymond Pratt, MD

Shire Pharmaceutical Development

More Information

Additional Information:

Synopsis of Study Results This link exits the ClinicalTrials.gov site

FDA-approved labelling information, US only This link exits the ClinicalTrials.gov site

FDA Recall information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

Publications:

Spencer TJ, Wilens TE, Biederman J, Weisler RH, Read SC, Pratt R. Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Feb;28(2):266-79.

Study ID Numbers:	SLI381-314A
Study First Received:	July 19, 2007
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00507065 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Adderall
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010