Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

This study has been completed.
Sponsor:
Collaborators:
American Heart Association
American College of Clinical Pharmacy
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00361283
First received: August 4, 2006
Last updated: April 16, 2012
Last verified: April 2012

August 4, 2006
April 16, 2012
June 2004
December 2008   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00361283 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Inflammation
Drug: Atorvastatin
atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Other Name: Lipitor
atorvastatin
80mg of atorvastatin given once daily for 16 weeks
Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
January 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00361283
0435278B
No
University of Florida
University of Florida
  • American Heart Association
  • American College of Clinical Pharmacy
Principal Investigator: Reginald Frye, PharmD, PhD University of Florida College of Pharmacy
University of Florida
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP