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)

Shire

Status and phase

Completed

Phase 3

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Drug: extended-release guanfacine hydrochloride

Drug: extended-release guanfacine hydrochloride (SPD503)

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00997984

SPD503-314

Details and patient eligibility

About

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.

Enrollment

340 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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