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Sponsors and Collaborators: |
Massachusetts General Hospital Shire Pharmaceutical Development |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00753012 |
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 an amphetamine (a stimulant). Amphetamines increase alertness and activity. They are considered safe and effective for treating ADHD in children. Less is known about the safety and effectiveness of stimulants when they are used to treat adults with ADHD. There have been some reports of sudden death in children and adults treated with stimulants. There is no definite evidence that the deaths were related to the use of stimulants. However, the deaths have raised questions about the effects that stimulants might have on such things as blood pressure and heart rate. The study will involve measuring your blood pressure both at home and in the office as well as cardiovascular tests at the main campus of MGH. The cardiovascular tests involved in the study are the 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).
We predict to see changes in blood pressure and heart rate (average increase of heart rate 3-7 bpm, 1-5 mmHg blood pressure) as shown in other clinical studies. We predict that cardiovascular tests, such as the stress test, will show higher resting heart rate and lower heart rate recovery during exercise on LDX in comparison to exercise off LDX. However, we do not expect to see any changes in heart and lung functioning on LDX as compared to off LDX.
Condition | Intervention | Phase |
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Attention Deficit/Hyperactivity Disorder(ADHD) |
Drug: Lisdexamfetamine (LDX; Vyvanse) |
Phase IV |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment |
Official Title: | An In Depth Cardiovascular Study of Lisdexamfetamine (LDX; Vyvanse) in Healthy and Treated Hypertensive Adults With Attention Deficit Hyperactivity Disorder (ADHD) |
Estimated Enrollment: | 36 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Adults who meet DSM-IV-TR criteria for ADHD. Group 1 is normotensive adults; Group 1 does not have high blood pressure. Group 2 is primary hypertensive adults; Group 2 does have high blood pressure and is being treated with stable doses of up to two FDA approved hypertensive medications achieving a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg. |
Drug: Lisdexamfetamine (LDX; Vyvanse)
Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking 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.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
In phase two; hypertension is not exclusionary, however blood pressure with antihypertensive treatment of
Contact: Meghan Kotarski, MBA | mkotarski@partners.org | |
Contact: Courtney Williams, BA | cgwilliams@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Cambridge, Massachusetts, United States, 02138 | |
Contact: Meghan Kotarski, MBA mkotarski@partners.org | |
Contact: Courtney Williams, BA cgwilliams@partners.org | |
Principal Investigator: Paul Hammerness, MD |
Principal Investigator: | Paul Hammerness, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Paul Hammerness, MD ) |
Study ID Numbers: | 2008-P-000121 |
Study First Received: | September 12, 2008 |
Last Updated: | June 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00753012 History of Changes |
Health Authority: | United States: Institutional Review Board |
cardiovascular testing home blood pressure monitoring office home blood pressure monitoring cardiopulmonary exercise testing transthoracic echocardiography |
Lisdexamfetamine Vyvanse normotensive and hypertensive adults with ADHD ADHD medication. |
Dopamine Uptake Inhibitors Neurotransmitter Agents Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Healthy Dyskinesias Signs and Symptoms Dopamine |
Attention Deficit Disorder with Hyperactivity Mental Disorders Dextroamphetamine Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias Pharmacologic Actions |
Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Dextroamphetamine Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents Central Nervous System Agents |