Safety and Efficacy of ADDERALL XR in the Treatment of Adolescents Aged 13-17 With Attention Deficit Hyperactivity Disorder (ADHD)
Information source: Shire Pharmaceutical Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD
Intervention: Mixed salts of a single-entity amphetamine (ADDERALL XR) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Shire Pharmaceutical Development Official(s) and/or principal investigator(s):
Raymond Pratt, MD, Study Director, Affiliation: Shire Pharmaceutical Development
Summary
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).
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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
Eligibility
Minimum age: 13 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
New York University - Child Study Center, New York, New York, United States
Additional Information
Synopsis of Study Results FDA-approved labelling information, US only FDA Recall information FDA Medical Product Safety Alerts
Starting date: May 2003
Ending date: April 2004
Last updated: June 17, 2008
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