Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shire | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine | 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 hypertensive medications achieving a blood pressure of <135/85. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricle Size | Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE) | 3-6 months |
| Cardiac Function Index (E/A Ratio) | Left ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE) | 3-6 months |
| Blood Pressure at Maximum Exertion | Diastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET) | 3-6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Hammerness, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Normotensive Adults With ADHD | Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure. |
| FG001 | Primary Hypertensive Adults With ADHD | Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normotensive Adults With ADHD | Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure. |
| BG001 | Primary Hypertensive Adults With ADHD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Ventricle Size | Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE) | 14 subjects completed endpoint TTE; one HTN subject missed the scheduled endpoint TTE appointment. | Posted | Mean | Standard Deviation | mm | 3-6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normotensive Adults With ADHD | Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Hammerness | Massachusetts General Hospital | (503)617-1040 | phammerness@partners.org |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Confounded endpoint data |
|
Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Cardiac Function Index (E/A Ratio) | Left ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE) | Posted | Mean | Standard Deviation | cm/sec/cm/sec | 3-6 months |
|
|
|
| Primary | Blood Pressure at Maximum Exertion | Diastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET) | Posted | Mean | Standard Deviation | mmHg | 3-6 months |
|
|
|
| 0 |
| 14 |
| 11 |
| 14 |
| EG001 | Primary Hypertensive Adults With ADHD | Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg. | 0 | 8 | 8 | 8 |
| back pain | General disorders | Non-systematic Assessment |
|
| blind spot | Eye disorders | Non-systematic Assessment |
|
| blurred vision | Eye disorders | Non-systematic Assessment |
|
| cold symptoms | General disorders | Non-systematic Assessment |
|
| congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| depressed mood | Psychiatric disorders | Non-systematic Assessment |
|
| difficulty achieving erection | Reproductive system and breast disorders | Non-systematic Assessment |
|
| dry mouth | General disorders | Non-systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| feelings of self-consciousness | Psychiatric disorders | Non-systematic Assessment |
|
| fever | General disorders | Non-systematic Assessment |
|
| feeling flustered | Psychiatric disorders | Non-systematic Assessment |
|
| foot pain | General disorders | Non-systematic Assessment |
|
| GI upset | Gastrointestinal disorders | Non-systematic Assessment | Gastrointestinal upset |
|
| hand tremor | General disorders | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| heartburn | General disorders | Non-systematic Assessment |
|
| increased energy | General disorders | Non-systematic Assessment |
|
| insomnia | General disorders | Non-systematic Assessment |
|
| irritability | Psychiatric disorders | Non-systematic Assessment |
|
| jaw tension | General disorders | Non-systematic Assessment |
|
| jittery | General disorders | Non-systematic Assessment |
|
| lightheadedness | General disorders | Non-systematic Assessment |
|
| lip swelling | General disorders | Non-systematic Assessment |
|
| low appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| low energy | General disorders | Non-systematic Assessment |
|
| muscle aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| muscle tension | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| muscle twitch | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| nausea | General disorders | Non-systematic Assessment |
|
| numbness | General disorders | Non-systematic Assessment |
|
| racing | General disorders | Non-systematic Assessment | Feeling 'on the go' or 'driven by a motor' |
|
| sinus pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| tension | General disorders | Non-systematic Assessment |
|
| tightness in the hand | General disorders | Non-systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| viral illness | Infections and infestations | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |