ong-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)
Phase 1
- Conditions
- Attention-Deficit/Hyperactivity Disorder (AD/HD)MedDRA version: 23.0Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorderSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-000686-68-Outside-EU/EEA
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 228
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).;Secondary Objective: To measure:<br>a) 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)<br>b) Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)<br>c) Cytochrome P450 2D6 (CYP2D6) Phenotype Status ;Primary end point(s): Number of Participants With Adverse Events for Long Term Safety and Tolerability ;Timepoint(s) of evaluation of this end point: Baseline through 4 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): a) 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)<br>b) Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)<br>c) Cytochrome P450 2D6 (CYP2D6) Phenotype Status ;Timepoint(s) of evaluation of this end point: a) Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years <br>b) Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years <br>c) Over 1 year