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

Lilly

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Atomoxetine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00485407

B4Z-MC-LYCL

8226

Details and patient eligibility

About

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

Enrollment

377 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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