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 Pharmaceutical Development
Information obtained from ClinicalTrials.gov on June 20, 2008
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 Pharmaceutical Development 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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Overall Driving Safety Score derived by the driving simulator
Secondary outcome: Driving Safety Scores at individual time pointsCog-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 Medical Product Safety Alerts FDA-approved Label Synopsis of Study Results
Starting date: February 2004
Ending date: October 2004
Last updated: June 10, 2008
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