Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Information provided by:
Shire Identifier:
First received: July 19, 2007
Last updated: March 30, 2009
Last verified: November 2007

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
Drug: Mixed salts of a single-entity amphetamine (ADDERALL XR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Further study details as provided by Shire:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00507065

United States, New York
New York University - Child Study Center
New York, New York, United States
Sponsors and Collaborators
Study Director: Raymond Pratt, MD Shire
  More Information

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

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 27, 2015