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The purpose of this study is to evaluate the comparative long-term safety and efficacy of SPD503 in children and adolescents aged 6 to 17 years diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD) for whom stimulants are not suitable, not tolerated, or shown to be ineffective.
This study will be conducted in two parts Part A and Part B. Part A is a double-blinded, double-dummy, placebo-controlled study with an atomoxetine arm as an active reference to SPD503. Eligible participants will be randomized in a 1:1:1 ratio among SPD503, atomoxetine, and placebo treatment arms for the first 18 weeks of double-blinded treatment. At the end of the first 18 weeks, participants in the placebo treatment arm will rollover to Part B of the study directly for an additional 52 weeks of open-label SPD503 treatment. Participants in the SPD503 and atomoxetine treatment arms will continue in Part A of the study for the remainder of the 52 weeks. At the end of 52 weeks of double-blinded treatment and evaluation in Part A. Participants in the SPD503 and atomoxetine treatment arms will rollover into Part B of the study for an additional 1 year of open-label SPD503 treatment.
Guanfacine hydrochloride (SPD503), Atomoxetine hydrochloride, Placebo
Clinical Neuroscience Solutions, Inc.
Not yet recruiting
Published on BioPortfolio: 2019-09-17T02:47:47-0400
A study to evaluate the long term maintenance of efficacy of using Guanfacine Hydrochloride (SPD-503) for the treatment of ADHD in Children aged 6-17 years in Europe, Australia, Canada and...
The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
The overall primary objective of this study is to test the hypothesis that, compared with placebo,administration of atomoxetine will result in an improved work productivity.
The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit...
Berberine hydrochloride is one the effective compound among Rhizoma Coptidis, Cortex Phellodendri, and other plants. There are several clinical functions of berberine hydrochloride including anti-infl...
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A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
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A benzamide derivative that is used as a dopamine antagonist.
4(1-Naphthylvinyl)pyridine hydrochloride. Cholinesterase inhibitor. Synonym: YuB 25.
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Attention deficit hyperactivity disorder (ADHD)
Attention deficit hyperactivity disorder (ADHD) is a group of behavioural symptoms that include inattentiveness, hyperactivity and impulsiveness. Attention deficit disorder (ADD) is a sub-type of ADHD - symptoms of ADHD include: a short attenti...