Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Drug: SPD503 (3 mg)Drug: SPD503 (Guanfacine hydrochloride) (2 mg)Drug: SPD503 (4 mg)Drug: Placebo
- Registration Number
- NCT00152009
- Lead Sponsor
- Shire
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 345
- Subjects with a primary diagnosis of ADHD
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPD503 (3 mg) SPD503 (3 mg) - SPD503 (Guanfacine HCl) (2 mg) SPD503 (Guanfacine hydrochloride) (2 mg) - SPD503 (4 mg) SPD503 (4 mg) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks Baseline and up to 5 weeks Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks Baseline and up to 5 weeks The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks Baseline and up to 5 weeks The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) up to 5 weeks Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks Baseline and 5 weeks The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.
Number of Participants With Improvement in Parent Global Assessment (PGA) up to 5 weeks Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.