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

Phase 3CompletedNCT00191295

Eli Lilly and Company240 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

AtomoxetineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (24)

Outcomes

Primary Outcomes

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

Secondary Outcomes

Relationship between atomoxetine doses and both efficacy and safety variables

Plasma concentration of atomoxetine and its metabolites

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

Data from ClinicalTrials.gov

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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

Chiba, Japan

Fukui, Japan

Fukuoka, Japan

Hokkaido, Japan

Hyōgo, Japan

Ibaraki, Japan

Ishikawa, Japan

Kanagawa, Japan

Kumamoto, Japan

...and 14 more locations