Phase 4 N=108 Screening

Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT00361283 ↗

Enrolled (actual)

108

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Mean Change in Level: Week 16-baseline in Ena-78 — -111.2 pg/ml — p=0.15

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Atorvastatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Level: Week 16-baseline in Ena-78	-111.2	0.15

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00361283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.