Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17

Shire

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: SPD503 (4 mg); Drug: Placebo; Drug: SPD503 (3 mg); Drug: SPD503 (Guanfacine hydrochloride) (2 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152009

SPD503-301

Details and patient eligibility

About

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

Enrollment: 345 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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345 participants in 4 patient groups, including a placebo group

SPD503 (Guanfacine HCl) (2 mg)

Experimental group

Treatment:

Drug: SPD503 (Guanfacine hydrochloride) (2 mg)

SPD503 (3 mg)

Experimental group

Treatment:

Drug: SPD503 (3 mg)

SPD503 (4 mg)

Experimental group

Treatment:

Drug: SPD503 (4 mg)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo