Official Title: “A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder”

To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: guanfacine hydrochloride
  • Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4mg/day).
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Score on the oppositional subscale of the CPRS-R:L at 8 weeks
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• ADHD-RS
  • Time Frame: As Change from Baseline (approximately 13 weeks)
    Safety Issue?: No
• CGI-S
  • Time Frame: As Change from Baseline (approximately 8 weeks)
    Safety Issue?: No
• CGI-I
  • Time Frame: As Change from Baseline (approximately 8 weeks)
    Safety Issue?: No
• Conduct subscale of NYPRS-S
  • Time Frame: As Change from Baseline (approximately 8 weeks)
    Safety Issue?: No
• PSI/SF
  • Time Frame: As Change from Baseline (approximately 8 weeks)
    Safety Issue?: No
• MSS at 8 weeks
  • Time Frame: One administration at week 8
    Safety Issue?: No
• Safety and tolerability based on treatment-emergent adverse events, clinical laboratory tests, physical examinations, vital signs, and electrocardiograms
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Healthy subjects with ADHD and oppositional symptoms
• ADHD-RS>=24
• CGI >=4
• T-score of Opp subscale CPRS-R:L >=65
• Normal ECG and BP
• >= 55 lbs

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shire Pharmaceutical Development

Overall Clinical Trial Officials and Contacts

Thomas Spencer, M.D. Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367835

Study ID Number: SPD503-307

ClinicalTrials.gov Identifier: NCT00367835

Health Authority: United States: Food and Drug Administration