A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Stopped early · Phase 2

Conditions studied: Attention-Deficit/Hyperactivity Disorder

In brief

The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.

Key facts

Study ID

NCT00554385

Run by

Abbott

People needed

283

Starts

2007-11-01

Last updated by the study team

2011-08-23

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
• If female, subject must be practicing at least one method of birth control throughout the study.
• If female, the result of a pregnancy test is negative.
• The subject is judged to be in generally good health.

You may not qualify if…

• The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
• The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
• The subject has a positive urine drug screen for alcohol or drugs of abuse.
• The subject anticipates a move outside the geographic area.

Where it is running

• Site Ref #/Investigator 6800 — Little Rock, Arkansas, United States
• Site Ref #/Investigator 6812 — Boulder, Colorado, United States
• Site Ref #/Investigator 8366 — Bradenton, Florida, United States
• Site Ref #/Investigator 6808 — Jacksonville, Florida, United States
• Site Ref #/Investigator 6827 — Orlando, Florida, United States
• Site Ref #/Investigator 8383 — Libertyville, Illinois, United States
• Site Ref #/Investigator 6802 — Northbrook, Illinois, United States
• Site Ref #/Investigator 6824 — Overland Park, Kansas, United States
• Site Ref #/Investigator 8428 — Troy, Michigan, United States
• Site Ref #/Investigator 6902 — Omaha, Nebraska, United States
• Site Ref #/Investigator 6856 — Las Vegas, Nevada, United States
• Site Ref #/Investigator 6683 — Clementon, New Jersey, United States
• Site Ref #/Investigator 8297 — Oklahoma City, Oklahoma, United States
• Site Ref #/Investigator 6682 — Eugene, Oregon, United States
• Site Ref #/Investigator 6811 — Portland, Oregon, United States
• Site Ref #/Investigator 8701 — Portland, Oregon, United States
• Site Ref #/Investigator 6681 — Salem, Oregon, United States
• Site Ref #/Investigator 6799 — Charleston, South Carolina, United States
• Site Ref #/Investigator 7955 — Memphis, Tennessee, United States
• Site Ref #/Investigator 6836 — Austin, Texas, United States
• Site Ref #/Investigator 6835 — Herndon, Virginia, United States
• Site Ref #/Investigator 6791 — Bellevue, Washington, United States
• Site Ref #/Investigator 6838 — Middleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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