Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine
NCT ID: NCT00485407
Last Updated: 2007-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
377 participants
INTERVENTIONAL
2003-07-31
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Atomoxetine Hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
* Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
* Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test)
* Patients must be able to swallow capsules
Exclusion Criteria
* Patients with current or past Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
* Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control
* Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions
* Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
6 Years
16 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Scottsdale, Arizona, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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B4Z-MC-LYCL
Identifier Type: -
Identifier Source: secondary_id
8226
Identifier Type: -
Identifier Source: org_study_id