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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00554385 |
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.
Condition | Intervention | Phase |
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Attention-Deficit/Hyperactivity Disorder |
Drug: ABT-089 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Long-Term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study |
Enrollment: | 283 |
Study Start Date: | November 2007 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: ABT-089
Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.
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Ages Eligible for Study: | 6 Years to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Laura Gault, M.D., Ph.D. | Abbott |
Responsible Party: | Abbott ( Laura Gault, M.D., PhD Study Director ) |
Study ID Numbers: | M10-178 |
Study First Received: | November 5, 2007 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00554385 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Pathologic Processes Disease Nervous System Diseases |