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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00528697
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder Drug: ABT-089 Drug: atomoxetine Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children With Attention Deficit-Hyperactivity Disorder (ADHD)
Study Start Date : September 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Atomoxetine

Arm Intervention/treatment
Experimental: 1
Lowest ABT-089 dose
Drug: ABT-089
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.

Experimental: 2
Low-medium ABT-089 dose
Drug: ABT-089
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.

Experimental: 3
Medium-high ABT-089 dose
Drug: ABT-089
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.

Experimental: 4
Highest ABT-089 dose
Drug: ABT-089
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.

Active Comparator: 5
atomoxetine
Drug: atomoxetine
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.

Placebo Comparator: 6
placebo
Drug: placebo
Subject will take a tablet once daily for 8 weeks




Primary Outcome Measures :
  1. ADHD-RS-IV (HV) - Administered by study doctor [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56 ]

Secondary Outcome Measures :
  1. Health Outcomes Measurements [ Time Frame: Baseline to Final Evaluation of 8-week treatment period ]
  2. Clinical Global Impression-ADHD-Severity Scale [ Time Frame: Baseline to Final Evaluation of 8-week treatment period ]
  3. Parent Rating Scales [ Time Frame: Baseline to Final Evaluation of 8-week treatment period ]
  4. Teacher Rating Scale [ Time Frame: Baseline to Final Evaluation of 8-week treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have voluntarily signed an informed consent form
  • Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s)
  • First grade or higher in a school setting 3 days/week
  • Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG
  • Subject weighs at least 37 pounds (17 kg)
  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements
  • Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations

Exclusion Criteria:

  • Subject is not functioning at an age-appropriate level intellectually
  • Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
  • Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind
  • Subject has a history of significant allergic reaction to any drug
  • Subject requires ongoing treatment with any psychiatric medication
  • Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528697


Locations
Show Show 20 study locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Laura Gault, MD, PhD, MD AbbVie
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00528697    
Other Study ID Numbers: M06-888
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs