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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485407
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : November 1, 2007
Information provided by:
Eli Lilly and Company

June 11, 2007
June 13, 2007
November 1, 2007
July 2003
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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
Same as current
Complete list of historical versions of study NCT00485407 on Archive Site
  • 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
Same as current
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Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine
Guiding Dose Increases In Patients Incompletely Responsive to Usual Doses of Atomoxetine by Determining Plasma Atomoxetine Concentrations: a Randomized, Double-Blind Study
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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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
Drug: Atomoxetine Hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2005
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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
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Eli Lilly and Company
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP