CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 182 enrolled
Drug / intervention
SPD503 (Guanfacine HCl) +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Primary diagnosis of ADHD
  • ✓Baseline ADHD-RS-IV score ≥24 and CGI-S score ≥4
  • ✓Weight >55 lbs and not morbidly overweight
Key exclusion· 4
  • ✕Comorbid psychiatric diagnosis (except ODD) with significant symptoms, including severe Axis I or II disorders
  • ✕History of seizure disorder
  • ✕Specific cardiac condition or family history of significant cardiac condition
  • ✕Pregnant, lactating, or within six months post-partum

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

Search/NCT00150592
NCT00150592Phase 2Completed
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A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire·interventional·Posted Sep 8, 2005·Updated Jun 10, 2021

In Brief

A Phase 2 clinical trial evaluating SPD503 (Guanfacine HCl) and Placebo for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 182 participants.

Detailed Summary

The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartMay 12, 2005
Primary CompletionOct 5, 2005
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 20.8 years ago

Interventions

SPD503 (Guanfacine HCl)drug

Placebodrug