Status:
COMPLETED
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)
Lead Sponsor:
Shire
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief 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 me...
Eligibility Criteria
Inclusion
- 6-12 years old
- ADHD diagnosis
- ADHD-RS-IV minimum score of 28
- CGI-S score \> or = 4
Exclusion
- 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
Key Trial Info
Start Date :
November 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2010
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00997984
Start Date
November 17 2009
End Date
October 9 2010
Last Update
June 8 2021
Active Locations (46)
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1
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205
2
Valley Clinical Research, Inc.
El Centro, California, United States, 92243
3
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States, 90274
4
Psychiatric centers at San Diego, Feighner Research
San Diego, California, United States, 92108