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
ClinicalTrials.gov Identifier:
NCT00507065
First received: July 19, 2007
Last updated: March 4, 2015
Last verified: November 2007

July 19, 2007
March 4, 2015
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)
  • Drug: Placebo
  • Experimental: Adderall XR (10 mg)
    Intervention: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
  • Experimental: Adderall XR (20 mg)
    Intervention: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
  • Experimental: Adderall XR (30 mg)
    Intervention: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
  • Experimental: Adderall XR (40 mg)
    Intervention: Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507065
SLI381-314A
No
Not Provided
Not Provided
Not Provided
Shire
Not Provided
Study Director: Raymond Pratt, MD Shire
Shire
November 2007

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