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Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17

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ClinicalTrials.gov Identifier: NCT00152009
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : November 26, 2009
Last Update Posted : December 1, 2009
Sponsor:
Information provided by:
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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multi-Center, Double-Blind, 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 : January 2003
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SPD503 (Guanfacine HCl) (2 mg) Drug: SPD503 (Guanfacine hydrochloride) (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 Up to 5 Weeks [ Time Frame: Baseline and up to 5 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks [ Time Frame: Baseline and up to 5 weeks ]
  2. Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks [ Time Frame: Baseline and up to 5 weeks ]
  3. Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: up to 5 weeks ]
  4. Number of Participants With Improvement in Parent Global Assessment (PGA) [ Time Frame: up to 5 weeks ]
  5. Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks [ Time Frame: Baseline and 5 weeks ]


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

Inclusion Criteria:

  • Subjects with a primary diagnosis of ADHD
  • Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

  • 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

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00152009     History of Changes
Other Study ID Numbers: SPD503-301
First Posted: September 9, 2005    Key Record Dates
Results First Posted: November 26, 2009
Last Update Posted: December 1, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Guanfacine
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