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NCT00860847 · ClinicalTrials.gov registry record · Phase 3

Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)

A Phase 3 study of Coronary Atherosclerosis and Coronary Stenosis, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

Completed
Registry status
Phase 3
Development phase
65
Enrollment target
1
Study location

NCT00860847 is a Phase 3 study of Coronary Atherosclerosis and Coronary Stenosis that has completed, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 65 participants, below the 346-participant average among 5 other Coronary Atherosclerosis trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00860847, a Phase 3 study of Coronary Atherosclerosis and Coronary Stenosis, has completed, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

COMPLETED
Registry status
Phase 3
Development phase
65 participants
Enrollment target
1
Study location

Study Summary

1. Statement of Problem According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress. Cholesterol therapy has been well demonstrated to reduce coronary plaque progression. However is certainly not the only factor in evaluating for progression of coronary artery disease (CAD), and other factors must play a role. Garlic therapy has been shown to retard atherosclerosis independently. 2. Hypothesis and Specific Aims The hypothesis of this proposal is: In comparison to the placebo group, Aged Garlic Extract (AGE) therapy + Coenzyme Q10 (CoQ10) will be effective in slowing progression of coronary artery calcification (CAC) in firefighters with established atherosclerosis, independent of baseline blood pressure, statin use or other cardiovascular risk factors. Specific Aims: 1. Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract + CoQ10 or placebo. 2. Compare whether degree of change in atherosclerotic coronary artery plaque burden will change at a different rate under the influence of Aged Garlic Extract + CoQ10 compared to placebo treatment. 3. Compare whether Aged Garlic Extract + CoQ10 therapy induces changes in baseline values including biological and biochemical parameters, such as LDL cholesterol, homocysteine, C-reactive protein (CRP), and endothelial function.

Interventions

  • DIETARY_SUPPLEMENT Aged garlic extract and Coenzyme Q10

Study Locations (1)

California

  • Los Angeles Biomedical Research Institute - Torrance

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2009-05
Est. Completion 2010-09
Phase Phase 3

What the Registry Record Tells You About NCT00860847

The ClinicalTrials.gov registry entry for NCT00860847 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 346-participant average among 5 other Coronary Atherosclerosis trials with a reported enrollment target (81% lower). The listed sponsor is Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Coronary Atherosclerosis appearing as the primary indexed condition, and to 1 intervention - of which Aged garlic extract and Coenzyme Q10 is the first listed.

NCT00860847 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00860847 about?

NCT00860847 is a clinical study titled "Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)". 1. Statement of Problem According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress. Cholesterol therapy has been well demonstrated to reduce coronary plaque pro...

What is the current status of trial NCT00860847?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2009-05. Estimated completion is 2010-09.

What conditions does trial NCT00860847 study?

This clinical trial studies the following conditions: Coronary Atherosclerosis, Coronary Stenosis, Coronary Artery Calcification.

What interventions are being tested in trial NCT00860847?

The interventions under investigation include: Aged garlic extract and Coenzyme Q10 (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00860847?

This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00860847 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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