Efficacy and Safety of SPD503 in Combination With Psychostimulants

Shire

Status and phase: Completed; Phase 3

Conditions: ADHD

Treatments: Drug: Placebo; Drug: SPD503-AM; Drug: SPD503-PM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734578

SPD503-313

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

Enrollment: 461 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks
• Aged 6-17 years with a sub-optimal
• Partial response to stimulants
• Subjects must be < 95th percentile for BMI with weight >= 55lbs and <= 176lbs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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461 participants in 3 patient groups, including a placebo group

SPD503-AM

Experimental group

Description:

SPD503 (Guanfacine Extended Release)

Treatment:

Drug: SPD503-AM

SPD503-PM

Experimental group

Description:

SPD503 (Guanfacine Extended Release)

Treatment:

Drug: SPD503-PM

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo