Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379808
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2006-09-20
Brief Title:
Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether a particular substance involved in inflammation called leukotrienes is involved in causing heart disease to occur or to progress
Detailed Description:
The focus of this study is to better understand why some adults develop heart disease and others do not There are many known factors which play a role in causing heart disease such as diet and lifestyle Also we know that inflammation a process in the body which causes painful joints in arthritis or swelling at a site if injury also contributes to heart disease In particular we will address whether leukotrienes a component of inflammation is involved in promoting heart disease We will study this by giving subjects at high risk for heart disease a drug called montelukast which causes leukotrienes to have a reduced effect in the body In addition for comparison we will give other subjects a placebo for the same amount of time These subjects will then be crossed-over and will receive either montelukast or placebo depending on which treatment they received first We will compare these subjects using blood tests to see if subjects who take montelukast show signs of less inflammation caused by early heart disease as compared to subjects who do not
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AHA0615253B | OTHER_GRANT | American Heart Associatino | None |