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

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ClinicalTrials.gov Identifier: NCT00379808
Recruitment Status : Completed
First Posted : September 22, 2006
Results First Posted : July 23, 2012
Last Update Posted : July 23, 2012
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Coronary Heart Disease
Interventions Drug: montelukast
Drug: Placebo
Enrollment 22
Recruitment Details Patients were recruited based on flyers posted in public places, through recontact of patients in previous studies, and patients cared for in a family medicine clinic
Pre-assignment Details  
Arm/Group Title Placebo Then Montelukast Montelukast Then Placebo
Hide Arm/Group Description Patients were randomized in a crossover design to placebo or montelukast. Patients int this randomization arm received 4 weeks of placebo then 4 weeks of montelukast. There was no washout between crossover Patients were randomized in a crossover design to placebo or montelukast. Patients in this arm got montelukast for 4 weeks and then placebo for 4 weeks. There was no washout period
Period Title: Intervention Period 1 (4 Weeks)
Started 11 11
Completed 11 11
Not Completed 0 0
Period Title: Intervention Period 2 (4 Weeks)
Started 11 11
Completed 11 10
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title All Participants
Hide Arm/Group Description Patients were randomized in a crossover design, but baseline characteristics were presented for all participants. Likewise data are not separated by order of treatment because there were no order effects
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
All study participants Number Analyzed 22 participants
50.8  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
13
  59.1%
Male
9
  40.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title High-sensitivity C-reactive Protein
Hide Description measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
based on patients who completed the entire study
Arm/Group Title Placebo Montelukast
Hide Arm/Group Description:
This is all participants who received placebo, whether in first or second intervention
This is all patients who received montelukast, whether in the first or second intervention period
Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
1.0
(0.6 to 5.4)
1.0
(0.5 to 8.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Montelukast
Comments Statistical power was calculated using G*Power (Dusseldorf, Germany). Based on previously observed effects of statin drugs on hsCRP levels, 22 subjects provided 80% power to detect a moderate effect on hsCRP levels.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Wilcoxon sign rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title High Density Lipoprotein (HDL)-Cholesterol
Hide Description Lipid levels were determined at a clinical laboratory (Quest Diagnostics)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
those completing entire study
Arm/Group Title Placebo Montelukast
Hide Arm/Group Description:
This is all participants who received placebo, whether in first or second intervention
This is all patients who received montelukast, whether in the first or second intervention period
Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
52
(46 to 68)
50
(45 to 65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Montelukast
Comments Null hypothesis is that montelukast does not affect HDL. Not powered for this endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon sign rank
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 3.8
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Triglycerides
Hide Description measured by a clinical laboratory; Quest Laboratories
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
those completing the entire study
Arm/Group Title Placebo Montelukast
Hide Arm/Group Description:
This is all participants who received placebo, whether in first or second intervention
This is all patients who received montelukast, whether in the first or second intervention period
Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
94
(75 to 129)
104
(73 to 139)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Montelukast
Comments The null hypothesis is that montelukast does not affect triglycerides. The study was not powered to this outcome measure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method wilcoxon sign rank
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 7.4
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Monocyte Chemotactic Protein-1 (MCP-1)
Hide Description biomarker was measured by enzyme-linked immunosorbant assay (ELISA)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
those who completed the entire study
Arm/Group Title Placebo Montelukast
Hide Arm/Group Description:
This is all participants who received placebo, whether in first or second intervention
This is all patients who received montelukast, whether in the first or second intervention period
Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
84
(72 to 105)
94
(77 to 110)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Montelukast
Comments null hypothesis is that montelukast does not affect MCP-1. Study not powered to the biomarker.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Wilcoxon
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 11.9
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Interleukin 1 Receptor Antagonist (IL1ra)
Hide Description IL1ra was determined by enzyme-linked immunosorbant assay (ELISA)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
all participants who completed the entire study
Arm/Group Title Placebo Montelukast
Hide Arm/Group Description:
This is all participants who received placebo, whether in first or second intervention
This is all patients who received montelukast, whether in the first or second intervention period
Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
518
(400 to 828)
587
(429 to 1240)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Montelukast
Comments null hypothesis is that montelukast does not affect IL1ra.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method wilcoxon sign rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 13.3
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)
Hide Description biomarker determined by enzyme-linked immunosorbant assay.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
those completing the entire study
Arm/Group Title Placebo Montelukast
Hide Arm/Group Description:
This is all participants who received placebo, whether in first or second intervention
This is all patients who received montelukast, whether in the first or second intervention period
Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
631
(441 to 1190)
527
(175 to 1060)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Montelukast
Comments null hypothesis is that montelukast does not affect ENA-78. The study is not powered to this biomarker
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method wilcoxon sign rank
Comments [Not Specified]
Method of Estimation Estimation Parameter percent difference
Estimated Value 16.5
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Montelukast
Hide Arm/Group Description This is all participants who received placebo, whether in first or second intervention This is all patients who received montelukast, whether in the first or second intervention period
All-Cause Mortality
Placebo Montelukast
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Montelukast
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Montelukast
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%) 
Because there were no order effects, the placebo groups were combined and the montelukast groups were combined. Therefore results from each of these are not reported by arm.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Julie Johnson, PI
Organization: University of Florida
Phone: 352-273-6007
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00379808     History of Changes
Other Study ID Numbers: 06011312
AHA0615253B ( Other Grant/Funding Number: American Heart Associatino )
First Submitted: September 20, 2006
First Posted: September 22, 2006
Results First Submitted: February 14, 2012
Results First Posted: July 23, 2012
Last Update Posted: July 23, 2012