Coronary Heart DiseaseNCT00379808
Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease
A study testing montelukast in people with Coronary Heart Disease, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND
Who cannot join
- 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:
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Family Practice Medical Group Clinic
Gainesville, Florida, 32601
About this study
Official title: Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease
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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- montelukast, Placebo
- Keywords
- coronary heart disease, montelukast, inflammation
- Medical subject headings
- Coronary Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukastDrug
Also called Singulair
10 mg tablet (masked by capsule) daily for 1 month
PlaceboDrug
1 lactose-containing capsule daily for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 lactose-containing capsule daily for 1 month Receives: Drug: Placebo |
| Montelukast 10 mg | Active comparator | 1 montelukast 10 mg tablet (masked by capsule) daily for 1 month Receives: Drug: montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-sensitivity C-reactive Protein
measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)
Measured: 1 month
Secondary outcomes (1)
High Density Lipoprotein (HDL)-Cholesterol
Lipid levels were determined at a clinical laboratory (Quest Diagnostics)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Julie A Johnson, PharmD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379808
- Sponsor's protocol ID
- 06011312
- Other IDs
- AHA0615253B
- Status last verified
- Jun 2012
- First submitted
- 20 Sep 2006
- Last updated
- 23 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00379808
- Acronym / sponsor ID
- 06011312
- Conditions
- Coronary Heart Disease
- Keywords
- coronary heart disease, montelukast, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Sep 2006 (estimated)
- Results
- Posted 23 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo1 lactose-containing capsule daily for 1 month |
| Montelukast 10 mg | Active comparator | Drug: montelukast1 montelukast 10 mg tablet (masked by capsule) daily for 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| montelukastAlso: Singulair10 mg tablet (masked by capsule) daily for 1 month | Drug | Montelukast 10 mg |
| Placebo1 lactose-containing capsule daily for 1 month | Drug | Placebo |
Primary outcome
High-sensitivity C-reactive Protein
Time frame: 1 month
measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)
1 secondary outcome
High Density Lipoprotein (HDL)-Cholesterol
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Johnson, PharmD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing montelukast in people with Coronary Heart Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-sensitivity C-reactive Protein (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2012.