Clinical Trial: SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Tolerability of SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD),

Brief Summary: This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome:

  • Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
  • Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
  • Change From Baseline in Pulse Rate at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
  • Change From Baseline in Height at up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
  • Change From Baseline in Weight at up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
  • Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
    QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.
  • Change From Baseline in ECG QTcF Interval at up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
    The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.


Original Primary Outcome:

  • Systolic Blood Pressure [ Time Frame: up to 12 weeks ]
  • Diastolic Blood Pressure [ Time Frame: up to 12 weeks ]
  • Pulse Rate [ Time Frame: up to 12 weeks ]
  • Height [ Time Frame: up to 12 weeks ]
  • Weight [ Time Frame: up to 12 weeks ]
  • Electrocardiogram (ECG) Results (QRS interval) [ Time Frame: up to 12 weeks ]
  • ECG Results (QT interval) [ Time Frame: up to 12 weeks ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shire

Dates:
Date Received: November 9, 2011
Date Started: January 2012
Date Completion:
Last Updated: April 24, 2014
Last Verified: April 2014