CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 123 enrolled
Drug / intervention
SPD489 (Lisdexamfetamine dimesylate) +1 moredrug
Likely dose
SPD489 (Lisdexamfetamine dimesylate) 70mgfrom 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/NCT00877487
NCT00877487Phase 4Completed
CompareCT.gov

A Phase 4, Double-Blind, Multi-Center, Placebo-Controlled, Randomized Withdrawal, Safety and Efficacy Study of SPD489 in Adults Aged 18-55 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire·interventional·Posted Apr 7, 2009·Updated Jun 22, 2021

In Brief

A Phase 4 clinical trial evaluating SPD489 (Lisdexamfetamine dimesylate) and Placebo for Attention-Deficit/Hyperactivity Disorder. Completed, enrolled 123 participants across 55 sites.

Detailed Summary

The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and are maintained on their screening dose of commercial SPD489.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit/Hyperactivity Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2009
Enrollment StartApr 30, 2009
Primary CompletionJul 8, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.2 years ago

Interventions

SPD489 (Lisdexamfetamine dimesylate)drug

1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.

Placebodrug

1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.