Dataset from A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
收藏NIAID Data Ecosystem2026-05-02 收录
下载链接:
https://doi.org/10.25934/PR00007906
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资源简介:
While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy,
safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and
adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have
been of short duration - up to 8 weeks.
A number of long-term studies have been undertaken (up to 1 year) and these have confirmed
the safety and ongoing efficacy in this patient population.
In order to run a study with investigational medication within Poland the study changed to a
Phase 3 rather than a Phase 4 study in that country. Please note that the study number
remains as SPD489-404.
Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in
children and adolescents over a 2-year treatment period.
创建时间:
2024-11-26



