Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

The purpose of the study is to test whether atorvastatin (also known as Lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. We also are investigating whether or not genetic differences between people plays a role in the drug response.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18+ years old
Normocholesterolemic

Exclusion criteria

Cardiovascular disease or risk equivalents
Malignancy
Active alcohol abuse
Contraindications to statins
Interacting drugs
Chronic anti-inflammatory drugs

Treatment and study plan

atorvastatin

Drug

atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks

Other names: Lipitor

Primary outcomes

Mean Change in Level: Week 16-baseline in Ena-78

Time frame: 16 weeks after baseline

We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

American College of Clinical Pharmacy
American Heart Association

Registry information

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2009
First posted: Aug 8, 2006
Registry last updated: May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed