NCT00877487

Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	SPD489 (Lisdexamfetamine dimesylate)	1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.
DRUG	Placebo	1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.

Timeline

• Start date: 2009-04-30
• Primary completion: 2010-07-08
• Completion: 2010-07-08
• First posted: 2009-04-07
• Last updated: 2021-06-22
• Results posted: 2011-08-02

Locations

55 sites across 1 country: United States