Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

Completed · Not applicable · Has a placebo group

Conditions studied: Coronary Heart Disease

In brief

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.

Key facts

Study ID

NCT00379808

Run by

University of Florida

People needed

22

Starts

2006-07-01

Expected to finish

2009-08-01

Last updated by the study team

2012-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND

You may not qualify if…

• Current use of lipid-lowering medications
• Current use of montelukast
• Poorly controlled hypertension, where systolic blood pressure is greater than 160 or diastolic blood pressure is greater than 100
• Use of steroid drugs, non-steroidal anti-inflammatory drugs or other anti-inflammatory medications in the two weeks prior to enrollment. (low dose aspirin ( < 325 mg) is OK, but indication must be cardiovascular)
• Current recreational drug use
• Other cardiovascular disease or previous cardiovascular event. These include:
• history of angina pectoris
• history of heart failure
• presence of a cardiac pacemaker
• history of myocardial infarction
• previous revascularization procedure
• history cerebrovascular disease including stroke and transient ischemic attack
• Pregnancy or lactation
• Diabetes mellitus
• Lactose intolerance
• Contraindications to montelukast therapy
• Alcoholism
• Known hepatic disease
• Existing chronic obstructive pulmonary disease, asthma, allergic rhinitis
• Active chronic immune, infectious, neoplastic or inflammatory diseases requiring therapy (such as active Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV))
• Immunosuppressant therapy or known immunosuppression due to disease high density lipoprotein (HDL) < 40 mg/dL (although this would be a risk factor for heart disease, because of preliminary data which indicates that montelukast may lower HDL levels, we will exclude patients with abnormally low HDL from study)
• Other criteria at investigator discretion that are deemed to make the subject a poor candidate for the study

Where it is running

• University of Florida Family Practice Medical Group Clinic — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.