NCT00379808

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
3 years until next milestone

Results Posted

Study results publicly available

July 23, 2012

Completed
Last Updated

July 23, 2012

Status Verified

June 1, 2012

Enrollment Period

3 years

First QC Date

September 20, 2006

Results QC Date

February 14, 2012

Last Update Submit

June 7, 2012

Conditions

Coronary Heart Disease

Keywords

coronary heart diseasemontelukastinflammation

Outcome Measures

Primary Outcomes (1)

  • High-sensitivity C-reactive Protein

    measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)

    1 month

Secondary Outcomes (1)

  • High Density Lipoprotein (HDL)-Cholesterol

    1 month

Other Outcomes (4)

  • Triglycerides

    1 month

  • Monocyte Chemotactic Protein-1 (MCP-1)

    1 month

  • Interleukin 1 Receptor Antagonist (IL1ra)

    1 month

  • +1 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1 lactose-containing capsule daily for 1 month

Drug: Placebo

Montelukast 10 mg

ACTIVE COMPARATOR

1 montelukast 10 mg tablet (masked by capsule) daily for 1 month

Drug: montelukast

Interventions

montelukastDRUG

10 mg tablet (masked by capsule) daily for 1 month

Also known as: Singulair
Montelukast 10 mg
PlaceboDRUG

1 lactose-containing capsule daily for 1 month

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Family Practice Medical Group Clinic

Gainesville, Florida, 32601, United States

Location

MeSH Terms

Conditions

Coronary DiseaseInflammation

Interventions

montelukast

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Dr Julie Johnson, PI
Organization
University of Florida
johnson@cop.ufl.edu
352-273-6007

Study Officials

  • Julie A Johnson, PharmD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 22, 2006

Study Start

July 1, 2006

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

July 23, 2012

Results First Posted

July 23, 2012

Record last verified: 2012-06

Locations

US(1)