Status:

COMPLETED

SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms

Lead Sponsor:

Shire

Conditions:

ADHD

Eligibility:

All Genders

6-12 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 4 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 4 2008

    Estimated Enrollment :

    217 Patients enrolled

    Trial Details

    Trial ID

    NCT00367835

    Start Date

    December 4 2006

    End Date

    January 4 2008

    Last Update

    June 14 2021

    Active Locations (34)

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    Page 1 of 9 (34 locations)

    1

    HOPE Research Institute

    Phoenix, Arizona, United States, 85050

    2

    Valley Clinical Research

    El Centro, California, United States, 92243

    3

    Peninsula Research Associates Inc

    Rolling Hills Estates, California, United States, 90274

    4

    Sarkis Clinical Trials

    Gainesville, Florida, United States, 32607