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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00152009
First received: September 7, 2005
Last updated: November 25, 2009
Last verified: November 2009
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
  • Number of Participants With Improvement in Parent Global Assessment (PGA) [ Time Frame: up to 5 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 345
Study Start Date: January 2003
Study Completion Date: March 2006
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00152009     History of Changes
Other Study ID Numbers: SPD503-301
Study First Received: September 7, 2005
Results First Received: September 10, 2009
Last Updated: November 25, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Guanfacine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014