CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Lisdexamfetaminedrug
Likely dose
Lisdexamfetamine 30 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/NCT00753012
NCT00753012Phase 4Completed

An In Depth Cardiovascular Study of Lisdexamfetamine (LDX; Vyvanse) in Healthy and Treated Hypertensive Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Massachusetts General Hospital·interventional·Posted Sep 16, 2008·Updated Sep 24, 2012

In Brief

A Phase 4 clinical trial evaluating Lisdexamfetamine for Attention Deficit Hyperactivity Disorder (ADHD). Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this research study is to learn about the effects of a medication called Vyvanse on the heart (cardiovascular system). The U.S. Food and Drug Administration (FDA) has approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). People who have ADHD have trouble paying attention, organizing, and planning; these symptoms can cause problems at work, socially and at home. Vyvanse (also known as Lisdexamfetamine) is a stimulant class medication. There have been reports of serious cardiovascular effects in children and adults treated with stimulants. While there is no definite evidence that these events were related to the use of stimulants, the deaths have raised questions about the cardiovascular safety of stimulants. The study will involve in-depth cardiovascular tests, namely echocardiograph (ultrasound of the heart) and cardiopulmonary exercise test (also called stress test; subjects exercise on a bicycle while measuring their heart activity and breathing is monitored by cardiologists). The investigators predict to see changes in blood pressure and heart rate as shown in previous clinical studies, and that the in-depth cardiovascular tests will provide new insights into the cardiovascular impact of stimulants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsShire

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.8 years ago

Interventions

Lisdexamfetaminedrug

Lisdexamfetamine daily until the completion of participation in the clinical trial (up to Week 11 or final study visit). Subjects will start on 30 mg of LDX per day for the first week of treatment. The dose will be increased weekly in 20 mg increments, up to a 70 mg daily (maximum). If significant adverse effects (AE) occur, the daily dose may be reduced by 20 mg. At subsequent visits, a higher dose may be resumed if tolerated. Both cohorts of the study will follow the same treatment plan.