Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (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

PHASE3

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-29

Study Completion Date

2003-08-23

Brief Summary

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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

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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) (2 mg)

Group Type EXPERIMENTAL

SPD503 (Guanfacine hydrochloride) (2 mg)

Intervention Type DRUG

SPD503 (3 mg)

Group Type EXPERIMENTAL

SPD503 (3 mg)

Intervention Type DRUG

SPD503 (4 mg)

Group Type EXPERIMENTAL

SPD503 (4 mg)

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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SPD503 (Guanfacine hydrochloride) (2 mg)

Intervention Type DRUG

SPD503 (3 mg)

Intervention Type DRUG

SPD503 (4 mg)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with a primary diagnosis of ADHD
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria

* Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms
* History of seizure during the last 2 years
* Subject has any specific cardiac condition or family history of significant cardiac condition
* Subject is pregnant or lactating

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No