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