Phase 3
N=228
Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00191386 ↗Enrolled (actual)
228
Serious AEs
2.6%
Results posted
Nov 2010
Primary outcome: Primary: Number of Participants With Adverse Events for Long Term Safety and Tolerability — 6; 222 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atomoxetine hydrochloride (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events for Long Term Safety and Tolerability |
6; 222 | — |
| SECONDARY 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 |
-14.1; -16.0; -17.7; -20.0; -20.1 | <0.001 sig |
| SECONDARY Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) |
-1.1; -1.3; -1.4; -1.6; -1.8 | <0.001 sig |
| SECONDARY Cytochrome P450 2D6 (CYP2D6) Phenotype Status |
225; 3 | — |
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).
Eligibility 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
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
Data sourced from ClinicalTrials.gov (NCT00191386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.