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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00150618
First received: September 6, 2005
Last updated: November 25, 2009
Last verified: November 2009

September 6, 2005
November 25, 2009
April 2004
Not Provided
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
Score on ADHD Rating Scale at 6 weeks
Complete list of historical versions of study NCT00150618 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Number of Participants With Improvement in Parent Global Assessment (PGA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Conners' Parent Rating Scale-Revise Short Version
  • Clinical Global Impressions Scale
  • Parent's Global Assessment
  • Child Health Questionnaire
Not Provided
Not Provided
 
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
  • Drug: SPD503 (1 mg)
    Other Name: Guanfacine hydrochloride
  • Drug: SPD503 (2 mg)
  • Drug: SPD503 (3 mg)
  • Drug: SPD503 (4 mg)
  • Drug: Placebo
  • Experimental: SPD503 (Guanfacine HCl) (1 mg)
    Intervention: Drug: SPD503 (1 mg)
  • Experimental: SPD503 (2 mg)
    Intervention: Drug: SPD503 (2 mg)
  • Experimental: SPD503 (3 mg)
    Intervention: Drug: SPD503 (3 mg)
  • Experimental: SPD503 (4 mg)
    Intervention: Drug: SPD503 (4 mg)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Guanfacine Extended release in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Trial. Sallee FR, McGough J, Wigal T, et al. J. Am. Acad. Child Adolesc. Psychiatry, 2009; 48(2):155-165.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
324
May 2006
Not Provided

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00150618
SPD503-304
Not Provided
Not Provided
Shire
Not Provided
Not Provided
Shire
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP