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

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Shire

Status and phase

Completed
Phase 3

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: SPD503 (1 mg)
Drug: SPD503 (4 mg)
Drug: Placebo
Drug: SPD503 (2 mg)
Drug: SPD503 (3 mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150618
SPD503-304

Details and patient eligibility

About

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.

Enrollment

324 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

324 participants in 5 patient groups, including a placebo group

SPD503 (Guanfacine HCl) (1 mg)
Experimental group
Treatment:
Drug: SPD503 (1 mg)
SPD503 (2 mg)
Experimental group
Treatment:
Drug: SPD503 (2 mg)
SPD503 (3 mg)
Experimental group
Treatment:
Drug: SPD503 (3 mg)
SPD503 (4 mg)
Experimental group
Treatment:
Drug: SPD503 (4 mg)
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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