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N/A N=22 Randomized Triple-blind Treatment

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

Coronary Heart Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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