Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-16

Study Completion Date

2004-12-27

Brief Summary

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The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for 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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methylphenidate + SPD503

Group Type EXPERIMENTAL

Methylphenidate + SPD503 (Guanfacine hydrochloride)

Intervention Type DRUG

Amphetamine + SPD503

Group Type EXPERIMENTAL

Amphetamine + SPD503

Intervention Type DRUG

Interventions

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Methylphenidate + SPD503 (Guanfacine hydrochloride)

Intervention Type DRUG

Amphetamine + SPD503

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with a primary diagnosis of ADHD
* Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
* 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 and mild anxiety) 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