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Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inflammation

Intervention: Atorvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Reginald Frye, PharmD, PhD, Principal Investigator, Affiliation: University of Florida College of Pharmacy

Summary

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.

Clinical Details

Official title: Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

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

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Florida, Gainesville, Florida 32610, United States
Additional Information

Starting date: June 2004
Last updated: April 16, 2012

Page last updated: August 23, 2015

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