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

Long-Term Extension, Open-Label Study of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2017-000686-68-Outside-EU/EEA
Enrollment
Unknown
Registered
2021-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit/Hyperactivity Disorder (AD/HD) MedDRA version: 23.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873

Interventions

Trade Name: Strattera Product Name: Atomoxetine Hydrochloride Product Code: LY139603 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Atomoxetine hydrochloride CAS Number: 82248-59-7 Other desc

Sponsors

Eli Lilly and Company
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

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

MeasureTime frame
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) b) Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) 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 b) Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years c) Over 1 year—

Countries

Japan

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026