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

October 31, 2007 updated by: Eli Lilly and Company

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

377

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 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.
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 13, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2007

Last Update Submitted That Met QC Criteria

October 31, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8226
  • B4Z-MC-LYCL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Attention Deficit Hyperactivity Disorder

Clinical Trials on Atomoxetine Hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe