Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Inflammation Clinical Trial

Official title:

Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361283
• Other study ID #: 0435278B
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2006
• Last updated: April 16, 2012
• Start date: June 2004
• Est. completion date: January 2009

Study information

• Verified date: April 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	American College of Clinical Pharmacy, American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Level: Week 16-baseline in Ena-78	We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.	16 weeks after baseline	No