Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1553 participants
Study Classification
INTERVENTIONAL
Study Start Date
2000-08-31
Study Completion Date
2009-10-31
Brief Summary
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To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).
Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.
Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.
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Detailed Description
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Conditions
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Attention Deficit Hyperactivity Disorder
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Atomoxetine
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
Group Type
EXPERIMENTAL
atomoxetine
Intervention Type
DRUG
0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
Interventions
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atomoxetine
0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
Intervention Type
DRUG
Other Intervention Names
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LY139603
Strattera
Eligibility Criteria
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Inclusion Criteria
* Must be at least 6 years old but less than 18 years old when enrolled in first atomoxetine study
* Must meet the study criteria for ADHD
* Must be willing to have blood drawn and to complete other test required for this study
* Must meet the study criteria for ADHD
* Must be willing to have blood drawn and to complete other test required for this study
Exclusion Criteria
* allergic to more than 1 kind of medicine or have had multiple bad reactions to any drug
* taking certain medicines that could interact with atomoxetine
* plan to move too far away from a doctor participating in this study in the next 5 years
* current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study
* taking certain medicines that could interact with atomoxetine
* plan to move too far away from a doctor participating in this study in the next 5 years
* current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study
Minimum Eligible Age
6 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Eli Lilly
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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El Centro, California, United States
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Irvine, California, United States
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Lafayette, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Spring Valley, California, United States
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Walnut Creek, California, United States
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Norwich, Connecticut, United States
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Boca Raton, Florida, United States
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Gainsville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Boise, Idaho, United States
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Northbrook, Illinois, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Iowa City, Iowa, United States
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Bardstown, Kentucky, United States
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Lexington, Kentucky, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Cambridge, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Troy, Michigan, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, United States
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Moorestown, New Jersey, United States
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Piscataway, New Jersey, United States
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Manhasset, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Stony Brook, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Hershey, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Rydal, Pennsylvania, United States
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Dallas, Texas, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Vienna, Virginia, United States
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Spokane, Washington, United States
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Marshfield, Wisconsin, United States
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Middleton, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Wallsend, New South Wales, Australia
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South Brisbane, Queensland, Australia
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West Perth, Western Australia, Australia
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Antwerp, , Belgium
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Leuven, , Belgium
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Bordeaux, , France
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Lyon, , France
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Paris, , France
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Paris, , France
Site Status
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Heiligenstadt/Ofr, , Germany
Site Status
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Mannheim, , Germany
Site Status
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Holon, , Israel
Site Status
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Ness Ziona, , Israel
Site Status
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Cagliari, , Italy
Site Status
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Pisa, , Italy
Site Status
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Groningen, , Netherlands
Site Status
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Utrecht, , Netherlands
Site Status
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Oslo, , Norway
Site Status
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Rio Piedras, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Benmore, Sandown, South Africa
Site Status
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Garsfontein, , South Africa
Site Status
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Panorama, , South Africa
Site Status
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Gothenburg, , Sweden
Site Status
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Glasgow, Scotland, United Kingdom
Site Status
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Sheffield, South Yorkshire, United Kingdom
Site Status
Countries
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United States
Australia
Belgium
Canada
France
Germany
Israel
Italy
Netherlands
Norway
Puerto Rico
South Africa
Sweden
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Michelson D, Read HA, Ruff DD, Witcher J, Zhang S, McCracken J. CYP2D6 and clinical response to atomoxetine in children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):242-51. doi: 10.1097/01.chi.0000246056.83791.b6.
Reference Type
DERIVED
Other Identifiers
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B4Z-MC-LYAI
Identifier Type: OTHER
Identifier Source: secondary_id
4331
Identifier Type: -
Identifier Source: org_study_id
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