Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-12

Study Completion Date

2005-10-05

Brief Summary

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The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

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Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SPD503 (Guanfacine HCl)

Group Type EXPERIMENTAL

SPD503 (Guanfacine HCl)

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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SPD503 (Guanfacine HCl)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with a primary diagnosis of ADHD
* Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =\>4
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
* Subject weighs \> 55 lbs and is not morbidly overweight

Exclusion Criteria

* Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
* Subject has a history of seizure disorder
* Subject has any specific cardiac condition or family history of significant cardiac condition
* Subject is pregnant, lactating or within six month post-partum

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No