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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis|
- Mean Change in Level: Week 16-baseline in Ena-78 [ Time Frame: 16 weeks after baseline ] [ Designated as safety issue: No ]We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
|Study Start Date:||June 2004|
|Study Completion Date:||January 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
80mg of atorvastatin given once daily for 16 weeks
atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Other Name: Lipitor
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361283
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Reginald Frye, PharmD, PhD||University of Florida College of Pharmacy|