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Efficacy and Safety of SPD503 in Combination With Psychostimulants

NCT00734578 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2021-06-14

Study results available
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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.

Conditions

  • ADHD

Interventions

DRUG

SPD503-AM

SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg

DRUG

SPD503-PM

SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg

DRUG

Placebo

Placebo matched to Guanfacine Hydrochloride Extended Release

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-02
Primary Completion
2009-12-10
Completion
2009-12-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00734578 on ClinicalTrials.gov