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Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00361283
First Posted: August 8, 2006
Last Update Posted: May 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
American Heart Association
American College of Clinical Pharmacy
Information provided by (Responsible Party):
University of Florida
  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: None (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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00361283     History of Changes
Other Study ID Numbers: 0435278B
First Submitted: August 4, 2006
First Posted: August 8, 2006
Results First Submitted: March 9, 2012
Results First Posted: May 15, 2012
Last Update Posted: May 15, 2012
Last Verified: April 2012

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