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

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT00485407
• Lead Sponsor: Eli Lilly and Company

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-07
• Study Completion: 2005-06
• Status Verified: 2007-06
• Study First Submitted: 2007-06-11
• Study First Submitted QC: 2007-06-11
• Study First Posted: 2007-06-13
• Last Update Submitted: 2007-10-31
• Last Update Posted: 2007-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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