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

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Atomoxetine hydrochloride

• Registration Number: NCT00191386
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-08-24
• Results First Submitted QC: 2010-10-14
• Results First Posted: 2010-11-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-14
• Last Update Posted: 2010-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atomoxetine	Atomoxetine hydrochloride	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events for Long Term Safety and Tolerability	Baseline through 4 years	Details on the actual adverse events are presented in the Reported Adverse Events Section.

Secondary Outcome Measures

Name	Time	Method
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	Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years	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.
Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)	Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years	Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Cytochrome P450 2D6 (CYP2D6) Phenotype Status	Over 1 year	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.

Trial Locations

Locations (1)

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.; 🇯🇵 Wakayama, Japan