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OpenTrials
Completed

NCT Number: NCT00191295

Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Completed

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / 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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are diagnosed with ADHD
  • Patients must be able to swallow capsules
  • Patients must be of normal intelligence

Exclusion criteria

  • Patients who weigh less than 15 kg or more than 75 kg
  • Patients with organic brain disease (for example, dementia or traumatic brain injury residual)

Treatment and study plan

Atomoxetine

Drug

Placebo

Drug

Primary outcomes

  1. Change of total score on ADHD RS-IV-JParent Version: Investigation-Administered and Scored

Secondary outcomes

  1. Relationship between atomoxetine doses and both efficacy and safety variables

  2. Plasma concentration of atomoxetine and its metabolites

  3. Changes on ADHD RS-IV-J-School Version score

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder

Important dates

Study start
2005
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Nov 6, 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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