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
  Purpose

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.


Condition Intervention Phase
Inflammation
Drug: Atorvastatin
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


Enrollment: 108
Study Start Date: June 2004
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
atorvastatin
80mg of atorvastatin given once daily for 16 weeks
Drug: Atorvastatin
atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks
Other Name: Lipitor

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361283

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
American Heart Association
American College of Clinical Pharmacy
Investigators
Principal Investigator: Reginald Frye, PharmD, PhD University of Florida College of Pharmacy
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00361283     History of Changes
Other Study ID Numbers: 0435278B
Study First Received: August 4, 2006
Results First Received: March 9, 2012
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Inflammation
Arterial Occlusive Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014