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Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Primary Purpose

Inflammation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

atorvastatin

Arm Description

80mg of atorvastatin given once daily for 16 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2006
Last Updated
April 16, 2012
Sponsor
University of Florida
Collaborators
American Heart Association, American College of Clinical Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT00361283
Brief Title
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
Official Title
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
American Heart Association, American College of Clinical Pharmacy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atorvastatin
Arm Type
Other
Arm Description
80mg of atorvastatin given once daily for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Primary Outcome Measure Information:
Title
Mean Change in Level: Week 16-baseline in Ena-78
Description
We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.
Time Frame
16 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reginald Frye, PharmD, PhD
Organizational Affiliation
University of Florida College of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

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