Completed

Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

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What is being tested

Atorvastatin

Drug
Who is being recruted

Inflammation

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Phase 4
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorUniversity of Florida
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

All subjects received 16 weeks of Atorvastatin after a two week run in. Key dependent variables were the 16 week value minus the baseline value (post run-in). Last observation carried forward was used for missing values. The key comparisons are for two groups OATP1B1 reduced carriers and on-carriers and their association with Cytokines and Lipids. Secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.

Official TitleSystemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
NCT00361283
Principal SponsorUniversity of Florida
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
18+ years old

Normocholesterolemic

6 exclusion criteria prevent from participating
Active alcohol abuse

Cardiovascular disease or risk equivalents

Malignancy

Contraindications to statins

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

80mg of atorvastatin given once daily for 16 weeks

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Florida

Gainesville, United StatesOpen University of Florida in Google Maps
CompletedOne Study Center