Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

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. Identifier: NCT00361283
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : May 15, 2012
Last Update Posted : May 15, 2012
American Heart Association
American College of Clinical Pharmacy
Information provided by (Responsible Party):
University of Florida

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition: Inflammation
Intervention: Drug: Atorvastatin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
University of Florida Clinical Research Center. Study started June 2004 and ended January 9, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Atorvastatin 80mg of atorvastatin given once daily for 16 weeks

Participant Flow:   Overall Study
STARTED   108 
Lost to Follow-up                27 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Atorvastatin 80mg of atorvastatin given once daily for 16 weeks

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   107 
>=65 years   1 
[Units: Years]
Mean (Standard Deviation)
 31.6  (12.6) 
[Units: Participants]
Female   66 
Male   42 
Region of Enrollment 
[Units: Participants]
United States   108 

  Outcome Measures

1.  Primary:   Mean Change in Level: Week 16-baseline in Ena-78   [ Time Frame: 16 weeks after baseline ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Reginald F. Frye, PhD, Associate Professor
Organization: University of Florida
phone: 3522735453

Responsible Party: University of Florida 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