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Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

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ClinicalTrials.gov Identifier: NCT00361283
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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
No text entered.

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

Participant Flow:   Overall Study
    Atorvastatin
STARTED   108 
COMPLETED   81 
NOT COMPLETED   27 
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
  Description
Atorvastatin 80mg of atorvastatin given once daily for 16 weeks

Baseline Measures
   Atorvastatin 
Overall Participants Analyzed 
[Units: Participants]
 108 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   107 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.6  (12.6) 
Gender 
[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
No text entered.


  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
e-mail: fryerf@ufl.edu



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