CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 142 enrolled
Drug / intervention
LDX +1 moredrug
Likely dose
LDX 70 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/NCT00697515
NCT00697515Phase 3Completed

A Phase IIIb Randomized, Double-Blind, Multicenter, Placebo-Controlled, Dose Optimization, Crossover, Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Shire·interventional·Posted Jun 16, 2008·Updated Jun 9, 2021

In Brief

A Phase 3 clinical trial evaluating LDX and Placebo for ADHD. Completed, enrolled 142 participants across 5 sites.

Detailed Summary

To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2008
Enrollment StartJul 18, 2008
Primary CompletionDec 20, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.0 years ago

Interventions

LDXdrug

oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting

Placebodrug

Placebo administered once-daily for one week during the adult workplace environment setting