Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)

• Status: Completed
• Trial end date: 2010-10-09
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Guanfacine

Criteria

Inclusion Criteria:

• 6-12 years old

• ADHD diagnosis

• ADHD-RS-IV minimum score of 28

• CGI-S score > or = 4

Exclusion Criteria:

• Current, controlled or uncontrolled, comorbid psychiatric diagnosis

• Condition or illness which represent inappropriate risk to subject

• Known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia; orthostatic hypotension or controlled or uncontrolled hypertension

• Use of prohibited medication that have CNS effects or affect cognitive performance

• History of alcohol or substance abuse within 6 months

• Current use of medication that affect BP or heart rate

• Significantly overweight

• Weight of less than 55 lbs

• Known allergy to SPD503

• Abnormal urine drug and alcohol screen