A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder-Reference-Cited by-同舟云学术

A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder

Published:2020-11-01 Issue:9 Volume:30 Page:549-557
ISSN:1044-5463
Container-title:Journal of Child and Adolescent Psychopharmacology
language:en
Short-container-title:Journal of Child and Adolescent Psychopharmacology

Author:

Mattingly Greg¹,Arnold Valerie²,Yan Brian³,Yu Ming⁴,Robertson Brigitte⁴

Affiliation:

1. Midwest Research Group, St. Charles, Missouri, USA.

2. CNS Healthcare, Memphis, Tennessee, USA.

3. Biostatistics, Shire, a Member of the Takeda Group of Companies, Lexington, Massachusetts, USA.

4. Global Clinical Development, Shire, a Member of the Takeda Group of Companies, Lexington, Massachusetts, USA.

Publisher

Mary Ann Liebert Inc

Subject

Pharmacology (medical),Psychiatry and Mental health,Pediatrics, Perinatology, and Child Health

Link

https://www.liebertpub.com/doi/pdf/10.1089/cap.2020.0005

Reference23 articles.

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Washington, DC: American Psychiatric Association; 2013.

2. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: A Phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study

3. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SLI381 (Adderall XR) in Children With Attention-Deficit/Hyperactivity Disorder

4. SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results of a Randomized, Double-Blind Placebo-Controlled Study

5. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials

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1. A review of amphetamine extended release once-daily options for the management of attention-deficit hyperactivity disorder;Expert Review of Neurotherapeutics;2024-02-23

2. Pharmacokinetics, Safety, and Tolerability of SHP465 Mixed Amphetamine Salts After Administration of Multiple Daily Doses in Children Aged 4–5 Years with Attention-Deficit/Hyperactivity Disorder;CNS Drugs;2021-11-26