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A Study to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged Release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

2019-09-17 02:47:47 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Guanfacine hydrochloride (SPD503), Atomoxetine hydrochloride, Placebo

Location

Clinical Neuroscience Solutions, Inc.
Jacksonville
Florida
United States
32256

Status

Not yet recruiting

Source

Shire

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-17T02:47:47-0400

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