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

Shire

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: SPD503 (1 mg); Drug: SPD503 (4 mg); Drug: Placebo; Drug: SPD503 (2 mg); Drug: SPD503 (3 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150618

SPD503-304

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

Enrollment: 324 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a primary diagnosis of ADHD
• Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion criteria

• Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
• Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
• Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
• Subject is pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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324 participants in 5 patient groups, including a placebo group

SPD503 (Guanfacine HCl) (1 mg)

Experimental group

Treatment:

Drug: SPD503 (1 mg)

SPD503 (2 mg)

Experimental group

Treatment:

Drug: SPD503 (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