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

Official Title: “A Phase III, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)”

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

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SPD503 (Guanfacine HCl) (2 mg)
• Experimental: SPD503 (3 mg)
• Experimental: SPD503 (4 mg)
• Placebo Comparator: Placebo

Primary Measures

• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks
  • Time Frame: Baseline and up to 5 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks
  • Time Frame: Baseline and up to 5 weeks
    Safety Issue?: No
• Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks
  • Time Frame: Baseline and up to 5 weeks
    Safety Issue?: No
• Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
  • Time Frame: up to 5 weeks
    Safety Issue?: No
• Number of Participants With Improvement in Parent Global Assessment (PGA)
  • Time Frame: up to 5 weeks
    Safety Issue?: No
• Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks
  • Time Frame: Baseline and 5 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Shire Pharmaceutical Development Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00152009

Study ID Number: SPD503-301

ClinicalTrials.gov Identifier: NCT00152009

Health Authority: United States: Food and Drug Administration

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