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Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17

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ClinicalTrials.gov Identifier: NCT00150618
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : October 15, 2009
Last Update Posted : December 1, 2009
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: SPD503 (1 mg) Drug: SPD503 (2 mg) Drug: SPD503 (3 mg) Drug: SPD503 (4 mg) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : April 2004
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SPD503 (Guanfacine HCl) (1 mg) Drug: SPD503 (1 mg)
Other Name: Guanfacine hydrochloride
Experimental: SPD503 (2 mg) Drug: SPD503 (2 mg)
Experimental: SPD503 (3 mg) Drug: SPD503 (3 mg)
Experimental: SPD503 (4 mg) Drug: SPD503 (4 mg)
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ]
  2. Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 6 weeks ]
  3. Number of Participants With Improvement in Parent Global Assessment (PGA) [ Time Frame: 6 weeks ]
  4. Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00150618     History of Changes
Other Study ID Numbers: SPD503-304
First Posted: September 8, 2005    Key Record Dates
Results First Posted: October 15, 2009
Last Update Posted: December 1, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs