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Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

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Shire

Status and phase

Completed
Phase 2

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride)
Drug: Amphetamine + SPD503

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151996
SPD503-205

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17

Enrollment

75 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects with a primary diagnosis of ADHD
  • Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
  • 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 and mild anxiety) 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

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Methylphenidate + SPD503
Experimental group
Treatment:
Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride)
Amphetamine + SPD503
Experimental group
Treatment:
Drug: Amphetamine + SPD503

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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