N/A
N=22
Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00379808 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: High-sensitivity C-reactive Protein — 1.0; 1.0 mg/dl — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- montelukast (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High-sensitivity C-reactive Protein |
1.0; 1.0 | 0.22 |
| SECONDARY High Density Lipoprotein (HDL)-Cholesterol |
52; 50 | 0.57 |
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.
Eligibility Criteria
Inclusion Criteria
-Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00379808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.