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

Information source: Shire
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ADHD

Intervention: Mixed salts of a single-entity amphetamine (ADDERALL XR) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Raymond Pratt, MD, Study Director, Affiliation: Shire

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

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

FDA-approved labelling information, US only

FDA Recall information

Starting date: May 2003
Last updated: March 4, 2015

Page last updated: August 20, 2015

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