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ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: Mixed salts of a single-entity amphetamine (Drug); Atomoxetine hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Gary G Kay, PhD, Principal Investigator, Affiliation: Washington Neuropsychologica Institute, LLC

Summary

Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on simulated driving safety and performance of young adults with ADHD as measured by Driving Safety Scores derived by the Driving Simulator.

Clinical Details

Official title: A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With ADDERALL XR and STRATTERA Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall Driving Safety Score derived by the driving simulator

Secondary outcome:

Driving Safety Scores at individual time points

Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire

AEs, laboratory screens, PE, vital signs, ECG

Eligibility

Minimum age: 19 Years. Maximum age: 25 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- primary diagnosis of ADHD

- not naive to pharmacologic ADHD treatment

- valid driver's license with a minimum of 3 years driving experience

Exclusion Criteria:

- recent history of drug dependence or substance use disorder

- any specific cardiac condition that would, in the opinion of the investigator,

require exclusion

- history of seizure in last 2 years, tic disorder or Tourette's disorder

- female subject is pregnant or lactating

Locations and Contacts

Washington Neuropsychological Institute, LLC, Washington, District of Columbia, United States
Additional Information

FDA Recall Information

FDA-approved Label

Starting date: February 2004
Last updated: December 10, 2010

Page last updated: August 23, 2015

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