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...
Date First Received: September 6, 2005
Last Updated: November 2, 2007
Verified by: Shire Pharmaceutical Development, November 2007
Clinical Trial Phase: Phase 3 | Start Date: April 2004
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
Official Title: “A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Guanfacine hydrochloride
Outcome Measures for this Clinical Trial
Primary Measures
- Score on ADHD Rating Scale at 6 weeks
Secondary Measures
- Conners' Parent Rating Scale-Revise Short Version
- Clinical Global Impressions Scale
- Parent's Global Assessment
- Child Health Questionnaire
Criteria for Participation in this Clinical Trial
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
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
Clinical Trial Sponsor Information
Lead Sponsor: Shire Pharmaceutical Development
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150618
Study ID Number: SPD503-304
ClinicalTrials.gov Identifier: NCT00150618
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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