NCT00361283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 15, 2012

Completed
Last Updated

May 15, 2012

Status Verified

April 1, 2012

Enrollment Period

4.5 years

First QC Date

August 4, 2006

Results QC Date

March 9, 2012

Last Update Submit

April 16, 2012

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

  • 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.

    16 weeks after baseline

Study Arms (1)

atorvastatin

OTHER

80mg of atorvastatin given once daily for 16 weeks

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

atorvastatin 80mg tablets given by mouth once daily for 16 weeks with follow-up visits every 4 weeks

Also known as: Lipitor
atorvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years old
  • Normocholesterolemic

You may not qualify if:

  • Cardiovascular disease or risk equivalents
  • Malignancy
  • Active alcohol abuse
  • Contraindications to statins
  • Interacting drugs
  • Chronic anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Reginald F. Frye, PhD, Associate Professor
Organization
University of Florida
fryerf@ufl.edu
3522735453

Study Officials

  • Reginald Frye, PharmD, PhD

    University of Florida College of Pharmacy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2006

First Posted

August 8, 2006

Study Start

June 1, 2004

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

May 15, 2012

Results First Posted

May 15, 2012

Record last verified: 2012-04

Locations

US(1)