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NCT01048502 · ClinicalTrials.gov registry record · NA
Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01048502: Completed NA study, sponsored by University of Pennsylvania.
NCT01048502 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01048502, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purpose of this study is to better understand the anti-inflammatory benefits of two prescription medicines that are currently used to help people with cholesterol problems. Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help control cholesterol and reduce inflammation (the body's response to injury or sickness). Lovaza® is the brand name for prescription strength fish oil pills. In this study, we will be looking at how Lovaza® works to help reduce inflammation in healthy volunteers. Tricor® is the brand name for prescription fenofibrate pills. Fenofibrate is a prescription medicine that many doctors give to people with high triglyceride (fat in the blood) levels. In this study, we will be looking at how Tricor® works to help reduce inflammation in healthy volunteers. Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living) that can cause many of the effects similar to bacterial infections in humans. However, it can be administered in very small amounts to produce a mild immune response much the same as a 'flu' like illness. Within 1 ½ -3 hours after giving LPS by vein, a response consisting of fever, chills, headache, nausea and vomiting and generalized aches and pains will occur which lasts up to 6-8 hours. In addition to the flu like symptoms, the response causes temporary changes in cholesterol, triglycerides and blood sugar. Different people respond differently to LPS. We are using LPS in this study to bring on a temporary inflammatory response in the body and to compare the responses of people who receive Lovaza® or Tricor® to the responses of people who receive a placebo (pill that does not contain medicine).
Interventions
- DRUG Placebo
- DRUG Lovaza
- DRUG Fenofibrate (Tricor) tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01048502
The ClinicalTrials.gov registry entry for NCT01048502 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01048502 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01048502 about?
NCT01048502 is a clinical study titled "Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia". The purpose of this study is to better understand the anti-inflammatory benefits of two prescription medicines that are currently used to help people with cholesterol problems. Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help control cholesterol and reduc...
What is the current status of trial NCT01048502?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2010-01. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01048502?
The interventions under investigation include: Placebo (DRUG), Lovaza (DRUG), Fenofibrate (Tricor) tablets (DRUG).
Who is sponsoring clinical trial NCT01048502?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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