Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine
Completed · Phase 3
Conditions studied: Attention Deficit Hyperactivity Disorder
In brief
The purpose of this trial is to test the value of dose increases in patients with residual ADHD symptoms after treatment with the usual target dose of atomoxetine
Key facts
- Study ID
- NCT00485407
- Run by
- Eli Lilly and Company
- People needed
- 377
- Starts
- 2003-07-01
- Expected to finish
- 2005-06-01
- Last updated by the study team
- 2007-11-01
Who can join
Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Outpatients who are at least 6 years of age and not more than 16 years of age at Visit 1
- 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
You may not qualify if…
- Patients who weigh less than 25 kg or greater than 70 kg at study entry
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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