Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Drug: Placebo; Drug: LDX 50 mg; Drug: LDX 30 mg; Drug: LDX 70 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00735371

SPD489-305

Details and patient eligibility

About

The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

Enrollment: 314 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
• Baseline ADHD-RS-IV score >=28
• BP w/in 95th percentile for age, gender, and height

Exclusion criteria

• Subject has controlled or uncontrolled comorbid psychiatric diagnosis
• Subject has conduct disorder
• Suicidal
• Under or overweight
• Concurrent chronic or acute illness that might confound results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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314 participants in 4 patient groups, including a placebo group

Lisdexamfetamine Dimesylate (LDX) 30 mg

Active Comparator group

Treatment:

Drug: LDX 30 mg

LDX 50 mg

Active Comparator group

Treatment:

Drug: LDX 50 mg

LDX 70 mg

Active Comparator group

Treatment:

Drug: LDX 70 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo