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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
History of Changes
  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:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 19, 2013