Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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