CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 345 enrolled
Drug / intervention
SPD503 (Guanfacine hydrochloride) (2 mg) +3 moredrug
Likely dose
SPD503 (guanfacine hydrochloride) 2 mg, 3 mg, or 4 mgAI-extracted
Key inclusion· 1
  • ✓Primary diagnosis of ADHD
Key exclusion· 4
  • ✕Current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms
  • ✕History of seizure during the last 2 years
  • ✕Any specific cardiac condition or family history of significant cardiac condition
  • ✕Pregnant or lactating

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00152009
NCT00152009Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire·interventional·Posted Sep 9, 2005·Updated Jun 10, 2021

In Brief

A Phase 3 clinical trial evaluating SPD503 (Guanfacine hydrochloride) (2 mg), SPD503 (3 mg), and 2 other interventions for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 345 participants.

Detailed Summary

The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Disorder With Hyperactivity
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2005
Enrollment StartJan 29, 2003
Primary CompletionAug 23, 2003
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 20.8 years ago

Interventions

SPD503 (Guanfacine hydrochloride) (2 mg)drug

SPD503 (3 mg)drug

SPD503 (4 mg)drug

Placebodrug