The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
278
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
Subject will take a tablet once daily for 8 weeks
Site Reference ID/Investigator# 5999
Little Rock, Arkansas, United States
ADHD-RS-IV (HV) - Administered by study doctor
Time frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
Health Outcomes Measurements
Time frame: Baseline to Final Evaluation of 8-week treatment period
Clinical Global Impression-ADHD-Severity Scale
Time frame: Baseline to Final Evaluation of 8-week treatment period
Parent Rating Scales
Time frame: Baseline to Final Evaluation of 8-week treatment period
Teacher Rating Scale
Time frame: Baseline to Final Evaluation of 8-week treatment period
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Site Reference ID/Investigator# 5979
El Centro, California, United States
Site Reference ID/Investigator# 5986
Boulder, Colorado, United States
Site Reference ID/Investigator# 5993
Bradenton, Florida, United States
Site Reference ID/Investigator# 5995
Jacksonville, Florida, United States
Site Reference ID/Investigator# 5977
Orlando, Florida, United States
Site Reference ID/Investigator# 5981
Northbrook, Illinois, United States
Site Reference ID/Investigator# 5982
Overland Park, Kansas, United States
Site Reference ID/Investigator# 5992
Omaha, Nebraska, United States
Site Reference ID/Investigator# 5997
Las Vegas, Nevada, United States
...and 10 more locations