Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)

Phase 3CompletedNCT00191386

Eli Lilly and Company228 enrolled

Overview

The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

228

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Atomoxetine hydrochlorideDRUG

0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who met all of the disease diagnostic and study criteria at Visit 2 of previous placebo-controlled study, completed the study * Patients wish to enter into this study Exclusion Criteria: * Patients whose families anticipate a move outside the geographic range of the investigative site, or who plan extended travel inconsistent with the recommended visit interval

Locations (24)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events for Long Term Safety and Tolerability

Details on the actual adverse events are presented in the Reported Adverse Events Section.

Time frame: Baseline through 4 years

Secondary Outcomes

Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.

Time frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years

Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)

Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

Time frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years

Cytochrome P450 2D6 (CYP2D6) Phenotype Status

Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the \*2, \*3, \*4, \*5, \*6, \*7, \*8, and \*10 alleles. Metabolizer status was determined by focusing on the normal(wild type, \*2), decreased(\*10), and defective allele(\*3, \*4, \*5, \*6, \*7, or \*8). PM were assigned to the patients had two defective alleles in any combination of \*3, \*4, \*5, \*6, \*7, or \*8 alleles. EM was all except for PM.

Time frame: Over 1 year

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) Mon - Fri from 9 AM to 5 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