Table of contents
Trial overview
The available trial data on Atomoxetine Hydrochloride come from one interventional study in attention-deficit/hyperactivity disorder (ADHD).[1]
This study was completed and included 287 participants.[1]
Who was studied
The trial enrolled children and adolescents aged 6 to 17 years with ADHD.[1]
It focused on patients for whom stimulant treatment was not suitable, not tolerated, or ineffective.[1]
What was measured
The main safety endpoint was the change from baseline in the CANTAB RTI task.[1]
The CANTAB RTI task is a computer-based test used to measure reaction time, which helps show attention and psychomotor speed.[1]
The study also compared treatment effects after 12 months and assessed cognition using the total set of data.[1]
Trial design and phase
This was a Phase 3 interventional trial.[1]
Phase 3 studies usually test a treatment in a larger group of patients to better understand how well it works and how safe it is in real study conditions.[1]
Main study details
The study title shows that the trial compared TAK-503 with Atomoxetine Hydrochloride in children and adolescents with ADHD.[1]
The brief summary states that the key goal was to evaluate the long-term safety of TAK-503 and compare it with Atomoxetine Hydrochloride after 12 months of once-daily treatment.[1]
The intervention list includes oral Atomoxetine Hydrochloride and several matching tablet forms used in the study design.[1]
Because the source data are limited to one completed trial, the current evidence base here is focused on a single study rather than a broad group of trials.[1]
