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

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Shire

Status and phase

Completed
Phase 3

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: SPD503 (4 mg)
Drug: Placebo
Drug: SPD503 (3 mg)
Drug: SPD503 (Guanfacine hydrochloride) (2 mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00152009
SPD503-301

Details and patient eligibility

About

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

Enrollment

345 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

345 participants in 4 patient groups, including a placebo group

SPD503 (Guanfacine HCl) (2 mg)
Experimental group
Treatment:
Drug: SPD503 (Guanfacine hydrochloride) (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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