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NCT00753012 · ClinicalTrials.gov registry record · Phase 4
Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults
A Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00753012: Completed Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Massachusetts General Hospital.
NCT00753012 is a Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Massachusetts General Hospital. The registered enrollment target is 24 participants, below the 140-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00753012, a Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG Lisdexamfetamine
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
What the finished NCT00753012 record still lists
NCT00753012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 140-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 1 intervention - of which Lisdexamfetamine is the first listed.
NCT00753012 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00753012 about?
NCT00753012 is a clinical study titled "Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults". 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 troub...
What is the current status of trial NCT00753012?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2008-04. Estimated completion is 2011-03.
What conditions does trial NCT00753012 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD).
What interventions are being tested in trial NCT00753012?
The interventions under investigation include: Lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT00753012?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00753012 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Attention Deficit Hyperactivity Disorder (ADHD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00753012's enrollment target sits among peer trials
24 17th of 18 higher than 1 of 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder (ADHD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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