CompletedPhase 3

Efficacy and Safety of SPD503 in Combination With Psychostimulants

United States461 participantsStarted 2008-09-02

Plain-language summary

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

Who can participate

Age range6 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks * Aged 6-17 years with a sub-optimal * Partial response to stimulants * Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs

What they're measuring

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)

Timeframe: Baseline and weekly up to 8 weeks

Trial details

NCT IDNCT00734578

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12-10

Results submitted2010-10-22

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