SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms

Shire

Status and phase: Completed; Phase 3

Conditions: ADHD

Treatments: Drug: SPD503 (Guanfacine hydrochloride); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367835

SPD503-307

Details and patient eligibility

About

To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.

Enrollment: 217 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy subjects with ADHD and oppositional symptoms
• ADHD-RS>=24
• CGI >=4
• T-score of Opp subscale CPRS-R:L >=65
• Normal ECG and BP
• >= 55 lbs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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217 participants in 2 patient groups, including a placebo group

SPD503 (Guanfacine hydrochloride)

Experimental group

Treatment:

Drug: SPD503 (Guanfacine hydrochloride)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo