NCT00697515

Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study has both an optimization and double-blind period

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	LDX	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
DRUG	Placebo	Placebo administered once-daily for one week during the adult workplace environment setting

Timeline

• Start date: 2008-07-18
• Primary completion: 2008-12-20
• Completion: 2008-12-20
• First posted: 2008-06-16
• Last updated: 2021-06-09
• Results posted: 2010-02-01

Locations

5 sites across 1 country: United States