CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 215 enrolled
Drug / intervention
Extended-release Guanfacine HCl (Intuniv, SPD503)drug
Likely dose
Extended-release Guanfacine HCl (Intuniv, SPD503) 7 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01500694
NCT01500694Phase 3Completed
CompareCT.gov

A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316

Shire·interventional·Posted Dec 28, 2011·Updated Jun 16, 2021

In Brief

A Phase 3 clinical trial evaluating Extended-release Guanfacine HCl (Intuniv, SPD503) for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 215 participants across 60 sites in 13 countries.

Detailed Summary

For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder (ADHD)
CountriesAustria, Belgium, France, Germany, Ireland, Italy, Netherlands, Poland, Romania, Spain, Sweden, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2011
Enrollment StartMar 20, 2012
Primary CompletionSep 15, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 14.5 years ago

Interventions

Extended-release Guanfacine HCl (Intuniv, SPD503)drug

Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age