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

NCT00877487 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2021-06-22

Study results available
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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

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.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-07-08
Completion
2010-07-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877487 on ClinicalTrials.gov