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
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