NCT Number: NCT00485407
Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine
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
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Notify MeKey information
Conditions
Age range
6 year–16 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Test whether patients treated with atomoxetine 1.2 mg/kg/day who have sub-optimal clinical responses and peak plasma atomoxetine levels no higher than 800 ng/mL will benefit from a dose increase to 2.4 mg/kg/day
Secondary outcomes
-
Assess the relationship between plasma atomoxetine concentration levels and ADHD symptom response
-
Compare the efficacy of atomoxetine up to 2.4 mg/kg/day with atomoxetine at 1.2 mg/kg/day in reducing residual ADHD symptoms
-
Assess the safety and tolerability of atomoxetine at doses up to 2.4 mg/kg/day compared to 1.2 mg/kg/day in patients with peak plasma atomoxetine concentration levels no higher than 800 ng/mL as assessed by AEs elicited during open-ended questioning
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Lead sponsor
Eli Lilly and Company
Industry
Registry information
Official study title
Guiding Dose Increases In Patients Incompletely Responsive to Usual Doses of Atomoxetine by Determining Plasma Atomoxetine Concentrations: a Randomized, Double-Blind Study
Important dates
- Study start
- 2003
- Study completion
- 2005
- First posted
- Jun 13, 2007
- Registry last updated
- Nov 1, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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