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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.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00507065
First received: July 19, 2007
Last updated: March 30, 2009
Last verified: November 2007
History of Changes

July 19, 2007
March 30, 2009
May 2003
Not Provided
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 ]
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 ]
Complete list of historical versions of study NCT00507065 on ClinicalTrials.gov Archive Site
  • 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 ]
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. Adverse events, labs, physical exam, ECG [ Time Frame: Approximately 4 weeks ]
Not Provided
Not Provided
 
Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
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

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
ADHD
Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
329
April 2004
Not Provided

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
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507065
SLI381-314A
No
Not Provided
Shire Development LLC
Not Provided
Study Director: Raymond Pratt, MD Shire Development LLC
Shire Development LLC
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP